The following data is part of a premarket notification filed by Argosy Electronics with the FDA for Argosy Programmable Onque.
Device ID | K974242 |
510k Number | K974242 |
Device Name: | ARGOSY PROGRAMMABLE ONQUE |
Classification | Hearing Aid, Air Conduction |
Applicant | ARGOSY ELECTRONICS 10300 WEST 70TH ST. P.O. BOX 59072 Eden Prairie, MN 55344 |
Contact | Ronald A Scicluna |
Correspondent | Ronald A Scicluna 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 | 1997-11-12 |
Decision Date | 1998-01-20 |