The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Ks 5 - Clinical Audiometer.
| Device ID | K931322 |
| 510k Number | K931322 |
| Device Name: | KS 5 - CLINICAL 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 | 1993-03-16 |
| Decision Date | 1994-08-19 |