The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Maico Ma800 Audiometer.
Device ID | K911368 |
510k Number | K911368 |
Device Name: | MAICO MA800 AUDIOMETER |
Classification | Audiometer |
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 | EWO |
CFR Regulation Number | 874.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-28 |
Decision Date | 1991-06-26 |