EAR-A-GATOR
Device Facts
| Record ID | K946108 |
|---|---|
| Device Name | EAR-A-GATOR |
| Applicant | Life-Tech Intl., Inc. |
| Product Code | KHH · Ear, Nose, Throat |
| Decision Date | Jun 13, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.1800 |
| Device Class | Class 1 |
Regulatory Classification
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.
