The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Maico Ma630d Audiometer With Optional Reflex Decay & Eustachian Tube Function.
| Device ID | K953161 |
| 510k Number | K953161 |
| Device Name: | MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION |
| Classification | Tester, Auditory Impedance |
| 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 | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-07 |
| Decision Date | 1995-07-24 |