The following data is part of a premarket notification filed by Argosy Electronics with the FDA for Program 3-ch Ser Hear Aids W/program Fit Syst/pro Fit.
| Device ID | K944078 |
| 510k Number | K944078 |
| Device Name: | PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT |
| Classification | Hearing Aid, Air Conduction |
| Applicant | ARGOSY ELECTRONICS 10300 WEST 70TH ST. P.O. BOX 59072 Eden Prairie, MN 55344 |
| Contact | David A Preves |
| Correspondent | David A Preves ARGOSY ELECTRONICS 10300 WEST 70TH ST. P.O. BOX 59072 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 | 1994-08-22 |
| Decision Date | 1994-10-21 |