The following data is part of a premarket notification filed by Argosy Electronics with the FDA for K-amp 16, Hi-band K-amp, Ultra Compression & Hearing Protection/hearing Instrument.
| Device ID | K954038 |
| 510k Number | K954038 |
| Device Name: | K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT |
| Classification | Hearing Aid, Air Conduction |
| Applicant | ARGOSY ELECTRONICS 10300 W. 70TH ST. Eden Prairie, MN 55344 |
| Contact | David A Preves |
| Correspondent | David A Preves ARGOSY ELECTRONICS 10300 W. 70TH ST. Eden Prairie, MN 55344 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-28 |
| Decision Date | 1995-09-18 |