K943682 is an FDA 510(k) clearance for the SM-VEGA, SM-PC, SM-AGC, SM-AGC-H. This device is classified as a Hearing Aid, Air-conduction, Prescription (Class I - General Controls, product code ESD).
Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 17, 1994, 22 days after receiving the submission on July 26, 1994.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3300. An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid..
| 510(k) Number | K943682 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 1994 |
| Decision Date | August 17, 1994 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ESD - Hearing Aid, Air-conduction, Prescription |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.3300 |
| Definition | An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid. |