The following data is part of a premarket notification filed by Bernafon-maico, Inc. with the FDA for Maico Ma53.
| Device ID | K981142 |
| 510k Number | K981142 |
| Device Name: | MAICO MA53 |
| Classification | Audiometer |
| Applicant | BERNAFON-MAICO, INC. 9675 WEST 76TH ST. Eden Prairie, MN 55344 |
| Contact | Scott Savre |
| Correspondent | Scott Savre BERNAFON-MAICO, INC. 9675 WEST 76TH ST. Eden Prairie, MN 55344 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-30 |
| Decision Date | 1998-04-22 |