ARGOSY PROGRAMMABLE ONQUE

Hearing Aid, Air Conduction

ARGOSY ELECTRONICS

The following data is part of a premarket notification filed by Argosy Electronics with the FDA for Argosy Programmable Onque.

Pre-market Notification Details

Device IDK974242
510k NumberK974242
Device Name:ARGOSY PROGRAMMABLE ONQUE
ClassificationHearing Aid, Air Conduction
Applicant ARGOSY ELECTRONICS 10300 WEST 70TH ST. P.O. BOX 59072 Eden Prairie,  MN  55344
ContactRonald A Scicluna
CorrespondentRonald A Scicluna
ARGOSY ELECTRONICS 10300 WEST 70TH ST. P.O. BOX 59072 Eden Prairie,  MN  55344
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-12
Decision Date1998-01-20

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