K844275 is an FDA 510(k) clearance for the STARKET MODEL HMS. This device is classified as a Calibrator, Hearing Aid / Earphone And Analysis Systems (Class II - Special Controls, product code ETW).
Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 3, 1984, 28 days after receiving the submission on November 5, 1984.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3310.
| 510(k) Number | K844275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1984 |
| Decision Date | December 03, 1984 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| Product Code | ETW - Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3310 |