Ear，Nose，and Throat Devices
A亞部――總則（General Provisions）
874.1
范圍
Scope
874.3
有關(guān)上市前批準(zhǔn)生效日期的要求
Effective dates of requirement for premarket approval
874.9
聯(lián)邦食品、藥品和化妝品法（Federal Food, Drug, and Cosmetic Act，F(xiàn)DCA）第510（k）節(jié)的豁免限制
Limitations of exemptions from section 510（k） of the Federal Food, Drug, and Cosmetic Act （the act）
B亞部――診斷器械（Diagnostic Devices）
874.1050
聽(tīng)度計(jì)
Audiometer
874.1060
聽(tīng)力測(cè)試用聽(tīng)音室
Acoustic chamber for audiometric testing
874.1070
短增量靈敏度指數(shù)（SISI）適配器
Short increment sensitivity index （SISI） adapter
874.1080
聽(tīng)度計(jì)校準(zhǔn)裝置
Audiometer calibration set
874.1090
聽(tīng)覺(jué)阻抗檢測(cè)器
Auditory impedance tester
874.1100
聽(tīng)力測(cè)試用耳機(jī)墊
Earphone cushion for audiometric testing
874.1120
聽(tīng)力測(cè)試用電子噪聲發(fā)生器
Electronic noise generator for audiometric testing
874.1325
舌動(dòng)電流描記器
Electroglottograph
874.1500
味覺(jué)計(jì)
Gustometer
874.1800
空氣或水熱量刺激器
Air or water caloric stimulator
874.1820
外科神經(jīng)刺激器/定位器
Surgical nerve stimulator/locator
874.1925
托因比診斷管
Toynbee diagnostic tube
C亞部 [保留]（Reserved）
D亞部――修復(fù)器械（Prosthetic Devices）
874.3300
助聽(tīng)器
Hearing Aid
874.3310
助聽(tīng)器校準(zhǔn)器與分析系統(tǒng)
Hearing aid calibrator and analysis system
874.3320
集體助聽(tīng)器或集體聽(tīng)覺(jué)訓(xùn)練器
Group hearing aid or group auditory trainer
874.3330
主助聽(tīng)器
Master hearing aid
874.3375
電池驅(qū)動(dòng)的人工喉
Battery-powered artificial larynx
874.3400
耳鳴遮蔽器
Tinnitus masker
874.3430
中耳鑄模
Middle ear mold
874.3450
局部聽(tīng)小骨置換假體
Partial ossicular replacement prosthesis
874.3495
完整聽(tīng)小骨置換假體
Total ossicular replacement prosthesis
874.3540
聽(tīng)小骨置換手術(shù)用假體修復(fù)器具
Prosthesis modification instrument for ossicular replacement surgery
874.3620
耳鼻喉合成聚合物材料
Ear, nose, and throat synthetic polymer material
874.3695
顎植入面部假體
Mandibular implant facial prosthesis
874.3730
喉假體（Taub設(shè)計(jì)）
Laryngeal prosthesis （Taub design）
874.3760
球囊切開(kāi)釘（科迪釘）
Sacculotomy tack （Cody tack）
874.3820
內(nèi)淋巴分流器
Endolymphatic shunt
874.3850
帶閥門(mén)的內(nèi)淋巴分流管
Endolymphatic shunt tube with valve
874.3880
鼓膜穿刺管
Tympanostomy tube
874.3900
鼻擴(kuò)張器
Nasal dilator
874.3930
帶半滲透膜的鼓膜穿刺管
Tympanostomy tube with semipermeable membrane
874.3950
經(jīng)皮空氣傳導(dǎo)助聽(tīng)器系統(tǒng)
Transcutaneous air conduction hearing aid system
E亞部――手術(shù)器械（Surgical Devices）
874.4100
鼻出血球囊
Epistaxis balloon
874.4140
耳鼻喉圓頭銼
Ear, nose, and throat bur
874.4175
鼻咽導(dǎo)管
Nasopharyngeal catheter
874.4250
耳鼻喉電動(dòng)或氣動(dòng)手術(shù)鉆
Ear, nose, and throat electric or pneumatic surgical drill
874.4350
耳鼻喉光纖光源與傳輸體
Ear, nose, and throat fiberoptic light source and carrier
874.4420
耳鼻喉手動(dòng)手術(shù)設(shè)備
Ear, nose, and throat manual surgical instrument
874.4490
耳鼻喉科用氬激光器
Argon laser for otology, rhinology, and laryngology
874.4500
耳鼻喉顯微手術(shù)二氧化碳激光器
Ear, nose, and throat microsurgical carbon dioxide laser
874.4680
氣管鏡（柔性或剛性）及附件
Bronchoscope （flexible or rigid） and accessories
874.4710
食管鏡（柔性或剛性）及附件
Esophagoscope （flexible or rigid） and accessories
874.4720
縱隔鏡及附件
Mediastinoscope and accessories
874.4750
喉動(dòng)態(tài)鏡
Laryngostroboscope
874.4760
喉動(dòng)態(tài)鏡（柔性或剛性）及附件
Nasopharyngoscope （flexible or rigid） and accessories
874.4770
耳鏡
Otoscope
874.4780
鼻內(nèi)夾板
Intranasal splint
874.4800
骨粒收集器
Bone particle collector
F亞部 ――治療器械（Therapeutic Devices）
874.5220
耳鼻喉給藥裝置
Ear, nose, and throat drug administration device
874.5300
耳鼻喉檢查與治療裝置
Ear, nose, and throat examination and treatment unit
874.5350
抽吸式抗窒息裝置
Suction antichoke device
874.5370
抗窒息夾具
Tongs antichoke device
874.5550
電動(dòng)鼻清洗器
Powered nasal irrigator
874.5800
鼻外夾板
External nasal splint
874.5840
治療口吃裝置
Antistammering device
A亞部――總則（General Provisions）
874.1
范圍
Scope
874.3
有關(guān)上市前批準(zhǔn)生效日期的要求
Effective dates of requirement for premarket approval
874.9
聯(lián)邦食品、藥品和化妝品法（Federal Food, Drug, and Cosmetic Act，F(xiàn)DCA）第510（k）節(jié)的豁免限制
Limitations of exemptions from section 510（k） of the Federal Food, Drug, and Cosmetic Act （the act）
B亞部――診斷器械（Diagnostic Devices）
874.1050
聽(tīng)度計(jì)
Audiometer
874.1060
聽(tīng)力測(cè)試用聽(tīng)音室
Acoustic chamber for audiometric testing
874.1070
短增量靈敏度指數(shù)（SISI）適配器
Short increment sensitivity index （SISI） adapter
874.1080
聽(tīng)度計(jì)校準(zhǔn)裝置
Audiometer calibration set
874.1090
聽(tīng)覺(jué)阻抗檢測(cè)器
Auditory impedance tester
874.1100
聽(tīng)力測(cè)試用耳機(jī)墊
Earphone cushion for audiometric testing
874.1120
聽(tīng)力測(cè)試用電子噪聲發(fā)生器
Electronic noise generator for audiometric testing
874.1325
舌動(dòng)電流描記器
Electroglottograph
874.1500
味覺(jué)計(jì)
Gustometer
874.1800
空氣或水熱量刺激器
Air or water caloric stimulator
874.1820
外科神經(jīng)刺激器/定位器
Surgical nerve stimulator/locator
874.1925
托因比診斷管
Toynbee diagnostic tube
C亞部 [保留]（Reserved）
D亞部――修復(fù)器械（Prosthetic Devices）
874.3300
助聽(tīng)器
Hearing Aid
874.3310
助聽(tīng)器校準(zhǔn)器與分析系統(tǒng)
Hearing aid calibrator and analysis system
874.3320
集體助聽(tīng)器或集體聽(tīng)覺(jué)訓(xùn)練器
Group hearing aid or group auditory trainer
874.3330
主助聽(tīng)器
Master hearing aid
874.3375
電池驅(qū)動(dòng)的人工喉
Battery-powered artificial larynx
874.3400
耳鳴遮蔽器
Tinnitus masker
874.3430
中耳鑄模
Middle ear mold
874.3450
局部聽(tīng)小骨置換假體
Partial ossicular replacement prosthesis
874.3495
完整聽(tīng)小骨置換假體
Total ossicular replacement prosthesis
874.3540
聽(tīng)小骨置換手術(shù)用假體修復(fù)器具
Prosthesis modification instrument for ossicular replacement surgery
874.3620
耳鼻喉合成聚合物材料
Ear, nose, and throat synthetic polymer material
874.3695
顎植入面部假體
Mandibular implant facial prosthesis
874.3730
喉假體（Taub設(shè)計(jì)）
Laryngeal prosthesis （Taub design）
874.3760
球囊切開(kāi)釘（科迪釘）
Sacculotomy tack （Cody tack）
874.3820
內(nèi)淋巴分流器
Endolymphatic shunt
874.3850
帶閥門(mén)的內(nèi)淋巴分流管
Endolymphatic shunt tube with valve
874.3880
鼓膜穿刺管
Tympanostomy tube
874.3900
鼻擴(kuò)張器
Nasal dilator
874.3930
帶半滲透膜的鼓膜穿刺管
Tympanostomy tube with semipermeable membrane
874.3950
經(jīng)皮空氣傳導(dǎo)助聽(tīng)器系統(tǒng)
Transcutaneous air conduction hearing aid system
E亞部――手術(shù)器械（Surgical Devices）
874.4100
鼻出血球囊
Epistaxis balloon
874.4140
耳鼻喉圓頭銼
Ear, nose, and throat bur
874.4175
鼻咽導(dǎo)管
Nasopharyngeal catheter
874.4250
耳鼻喉電動(dòng)或氣動(dòng)手術(shù)鉆
Ear, nose, and throat electric or pneumatic surgical drill
874.4350
耳鼻喉光纖光源與傳輸體
Ear, nose, and throat fiberoptic light source and carrier
874.4420
耳鼻喉手動(dòng)手術(shù)設(shè)備
Ear, nose, and throat manual surgical instrument
874.4490
耳鼻喉科用氬激光器
Argon laser for otology, rhinology, and laryngology
874.4500
耳鼻喉顯微手術(shù)二氧化碳激光器
Ear, nose, and throat microsurgical carbon dioxide laser
874.4680
氣管鏡（柔性或剛性）及附件
Bronchoscope （flexible or rigid） and accessories
874.4710
食管鏡（柔性或剛性）及附件
Esophagoscope （flexible or rigid） and accessories
874.4720
縱隔鏡及附件
Mediastinoscope and accessories
874.4750
喉動(dòng)態(tài)鏡
Laryngostroboscope
874.4760
喉動(dòng)態(tài)鏡（柔性或剛性）及附件
Nasopharyngoscope （flexible or rigid） and accessories
874.4770
耳鏡
Otoscope
874.4780
鼻內(nèi)夾板
Intranasal splint
874.4800
骨粒收集器
Bone particle collector
F亞部 ――治療器械（Therapeutic Devices）
874.5220
耳鼻喉給藥裝置
Ear, nose, and throat drug administration device
874.5300
耳鼻喉檢查與治療裝置
Ear, nose, and throat examination and treatment unit
874.5350
抽吸式抗窒息裝置
Suction antichoke device
874.5370
抗窒息夾具
Tongs antichoke device
874.5550
電動(dòng)鼻清洗器
Powered nasal irrigator
874.5800
鼻外夾板
External nasal splint
874.5840
治療口吃裝置
Antistammering device