The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Ma630 Imped Screener/ma640 Imped/audiomet Screener.
| Device ID | K905704 |
| 510k Number | K905704 |
| Device Name: | MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER |
| Classification | Tester, Auditory Impedance |
| Applicant | MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2029 |
| Contact | Lois Donnay |
| Correspondent | Lois Donnay MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2029 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-21 |
| Decision Date | 1991-04-30 |