KHH · Stimulator, Caloric-Air
Ear, Nose, Throat · 21 CFR 874.1800 · Class 1
Overview
| Product Code | KHH |
|---|---|
| Device Name | Stimulator, Caloric-Air |
| 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.
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950785 | HORTMANN AIRMATIC AIR CALORIC STIMULATOR | Jedmed Instrument Co. | Jun 28, 1995 | SESE |
| K946108 | EAR-A-GATOR | Life-Tech Intl., Inc. | Jun 13, 1995 | SESE |
| K941325 | WATER IRRIGATOR, W1 200 | Strong Medical, Inc. | Aug 9, 1994 | SESE |
| K931608 | NCA-200 | Ics Medical Corp. | Jun 22, 1993 | SESE |
| K925237 | AUTOMATIC CALORIC IRRIGATION SYSTEM | Ics Medical Corp. | May 5, 1993 | SESE |
| K881630 | AUTOMATIC CALORIC IRRIGATION SYSTEM | Ics Medical Corp. | Jun 21, 1988 | SESE |
| K822179 | FRENZEL EYEGLASSES & RELATED ITEMS | Kelleher Corp. | Sep 21, 1982 | SESE |
Top Applicants
- Ics Medical Corp. — 3 clearances
- Strong Medical, Inc. — 1 clearance
- Life-Tech Intl., Inc. — 1 clearance
- Kelleher Corp. — 1 clearance
- Jedmed Instrument Co. — 1 clearance
