The following data is part of a premarket notification filed by Madsen North America, Inc. with the FDA for Micromate 304.
| Device ID | K896401 |
| 510k Number | K896401 |
| Device Name: | MICROMATE 304 |
| Classification | Audiometer |
| Applicant | MADSEN NORTH AMERICA, INC. 908 NIAGARA FALLS BLVD. North Tonawanda, NY 14120 |
| Contact | Zoila A Seery |
| Correspondent | Zoila A Seery MADSEN NORTH AMERICA, INC. 908 NIAGARA FALLS BLVD. North Tonawanda, NY 14120 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-07 |
| Decision Date | 1990-03-27 |