The following data is part of a premarket notification filed by Magnatone Hearing Aid Corp. with the FDA for Magnatone Model M Prewired Faceplate Hearing Aid.
| Device ID | K944241 |
| 510k Number | K944241 |
| Device Name: | MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MAGNATONE HEARING AID CORP. 170 N. CYPRESS WAY P.O. BOX 180964 Casselberry, FL 32718 -0964 |
| Contact | Tony Quick |
| Correspondent | Tony Quick MAGNATONE HEARING AID CORP. 170 N. CYPRESS WAY P.O. BOX 180964 Casselberry, FL 32718 -0964 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-31 |
| Decision Date | 1994-11-16 |