K821908 is an FDA 510(k) clearance for the STARKEY MODEL HAL-1. 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. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1982, 36 days after receiving the submission on June 28, 1982.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3310.
| 510(k) Number | K821908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 1982 |
| Decision Date | August 03, 1982 |
| Days to Decision | 36 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 |