The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Series Mcaxx (model 851) Ite Hearing Aid.
| Device ID | K903583 |
| 510k Number | K903583 |
| Device Name: | SERIES MCAXX (MODEL 851) ITE HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2029 |
| Contact | Dianne Tarter |
| Correspondent | Dianne Tarter 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 | 1990-08-08 |
| Decision Date | 1990-10-09 |