K946108 is an FDA 510(k) clearance for the EAR-A-GATOR. This device is classified as a Stimulator, Caloric-air (Class I — General Controls, product code KHH).
Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on June 13, 1995, 181 days after receiving the submission on December 14, 1994.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1800.
| 510(k) Number | K946108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1994 |
| Decision Date | June 13, 1995 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | KHH — Stimulator, Caloric-air |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 874.1800 |