The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for 2400 Audiometer, Impedance Meter & Hrng. Aid Analy.
| Device ID | K890842 |
| 510k Number | K890842 |
| Device Name: | 2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY |
| 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 | 1989-02-21 |
| Decision Date | 1989-06-07 |