Anesthesiology
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- Subpart B—Diagnostic DevicesCFR Sub-Part
- ETKTube, Toynbee Diagnostic1Product Code
- ETMGustometer, Sterile1Product Code
- ETNStimulator, Nerve2Product Code
- ETPStimulator, Caloric-Water1Product Code
- ETRAdaptor, Short Increment Sensitivity Index (Sisi)1Product Code
- ETSGenerator, Electronic Noise (For Audiometric Testing)2Product Code
- ETTCushion, Earphone (For Audiometric Testing)1Product Code
- ETYTester, Auditory Impedance2Product Code
- EWASet, Audiometer Calibration1Product Code
- EWCChamber, Acoustic (For Audiometric Testing)1Product Code
- EWOAudiometer2Product Code
- KHHStimulator, Caloric-Air1Product Code
- KLXElectroglottograph2Product Code
- LYNApparatus, Visual Reinforcement Audiometric2Product Code
- NASTympanometer2Product Code
- NNJGustometer, Non-Sterile1Product Code
- NRKKit, Test, Olfactory2Product Code
- PTOTester, Auditory Impedance, Exempt2Product Code
- PTPTympanometer, Exempt2Product Code
- LWIUltrasound, Sinus2Product Code
- PSVUltrasound Bronchoscope2Product Code
- QJGDevice System, Imaging, Tympanic Membrane And Middle Ear2Product Code
- QQEImage Management Software For Planning Of Otologic And Neurotologic Procedures2Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Stimulator, Caloric-Water
- Page Type
- Product Code
- Regulation Medical Specialty
- Ear, Nose, Throat
- Review Panel
- Ear, Nose, Throat
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 874.1800
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 874.1800 Air or water caloric stimulator
§ 874.1800 Air or water caloric stimulator.
(a) Identification. An air or water caloric stimulator is a device that delivers a stream of air or water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produce involuntary eye movements that are measured and recorded by a nystagmograph.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]