The following data is part of a premarket notification filed by Magnatone Hearing Aid Corp. with the FDA for Futura 67m, 68m, Megapowermp97, Integra 70,71,72,73, Supra 51,52, Supra 56,57,58,59, Suprema 45, 46, 47,48.
| Device ID | K973861 |
| 510k Number | K973861 |
| Device Name: | FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MAGNATONE HEARING AID CORP. P.O. BOX 180964 Casselberry, FL 32718 -0964 |
| Contact | Don E K. Campbell |
| Correspondent | Don E K. Campbell MAGNATONE HEARING AID CORP. 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 | 1997-10-09 |
| Decision Date | 1997-11-19 |