K897023 is an FDA 510(k) clearance for the OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID. This device is classified as a Face Plate Hearing Aid (Class I - General Controls, product code LRB).
Submitted by Audina Hearing Instrument (Longwood, US). The FDA issued a Cleared decision on March 16, 1990, 87 days after receiving the submission on December 19, 1989.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3300.
| 510(k) Number | K897023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 1989 |
| Decision Date | March 16, 1990 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | LRB — Face Plate Hearing Aid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.3300 |