ETP · Stimulator, Caloric-Water
Ear, Nose, Throat · 21 CFR 874.1800 · Class 1
Overview
| Product Code | ETP |
|---|---|
| Device Name | Stimulator, Caloric-Water |
| Regulation | 21 CFR 874.1800 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
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.
Classification Rationale
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.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863615 | ENTHERMO IRRIGATION UNIT | Jedmed Instrument Co. | Dec 16, 1986 | SESE |
| K820775 | VESTIBULARISET | Jedmed Instrument Co. | Nov 3, 1982 | SESE |
| K821481 | NASAL-THROAT SPRAY IRRIGATION INSTRUM. | Ethicare Products | Jun 14, 1982 | SESE |
| K813552 | MODEL 3000C CALORIC IRRIGATOR | Life-Tech Intl., Inc. | Feb 22, 1982 | SESE |
| K800443 | HYGROTHERM | Jedmed Instrument Co. | Mar 10, 1980 | SESE |
| K800442 | VARIOTHERM | Jedmed Instrument Co. | Mar 10, 1980 | SESE |
Top Applicants
- Jedmed Instrument Co. — 4 clearances
- Ethicare Products — 1 clearance
- Life-Tech Intl., Inc. — 1 clearance
