K873031 is an FDA 510(k) clearance for the STARKEY MODEL P1 MODULE. This device is classified as a Face Plate Hearing Aid (Class I - General Controls, product code LRB).
Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on February 8, 1988, 188 days after receiving the submission on August 4, 1987.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3300.
| 510(k) Number | K873031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1987 |
| Decision Date | February 08, 1988 |
| Days to Decision | 188 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 |