The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Audiometer Ai1, Me1 And Sa1 & Master Hearing Aid.
Device ID | K890993 |
510k Number | K890993 |
Device Name: | AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID |
Classification | Audiometer |
Applicant | MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2029 |
Contact | Duane Smedsrud |
Correspondent | Duane Smedsrud MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2029 |
Product Code | EWO |
CFR Regulation Number | 874.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-27 |
Decision Date | 1989-10-12 |