K950785 is an FDA 510(k) clearance for the HORTMANN AIRMATIC AIR CALORIC STIMULATOR. This device is classified as a Stimulator, Caloric-air (Class I - General Controls, product code KHH).
Submitted by Jedmed Instrument Co. (St.Louis, US). The FDA issued a Cleared decision on June 28, 1995, 127 days after receiving the submission on February 21, 1995.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1800.
| 510(k) Number | K950785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1995 |
| Decision Date | June 28, 1995 |
| Days to Decision | 127 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 |