The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Maico In-the-ear Model Rd 201.
| Device ID | K946253 |
| 510k Number | K946253 |
| Device Name: | MAICO IN-THE-EAR MODEL RD 201 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2029 |
| Contact | Mike Czura |
| Correspondent | Mike Czura MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2029 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-23 |
| Decision Date | 1995-01-30 |