K790482 is an FDA 510(k) clearance for the MODEL 4107-2S, HEARING AID. This device is classified as a Hearing Aid, Air-conduction, Prescription (Class I - General Controls, product code ESD).
Submitted by Starkey Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 3, 1979, 26 days after receiving the submission on March 8, 1979.
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 | K790482 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1979 |
| Decision Date | April 03, 1979 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| 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. |