The following data is part of a premarket notification filed by Argosy Electronics with the FDA for Program 3-ch Series Hear Aids W/dt-1 Desktop Program.
Device ID | K944077 |
510k Number | K944077 |
Device Name: | PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM |
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 | 1994-10-12 |