The following data is part of a premarket notification filed by United Hearing Systems, Inc. with the FDA for Uhs Micronet Programmable Hearing Aids Models 901,902,903,906,909/programmer.
| Device ID | K970828 |
| 510k Number | K970828 |
| Device Name: | UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER |
| Classification | Hearing Aid, Air Conduction |
| Applicant | UNITED HEARING SYSTEMS, INC. 731-B NORWICH RD. Plainfield, CT 06374 |
| Contact | Ralph Campagna |
| Correspondent | Ralph Campagna UNITED HEARING SYSTEMS, INC. 731-B NORWICH RD. Plainfield, CT 06374 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-06 |
| Decision Date | 1997-05-28 |
| Summary: | summary |