PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM

Hearing Aid, Air Conduction

ARGOSY ELECTRONICS

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.

Pre-market Notification Details

Device IDK944077
510k NumberK944077
Device Name:PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM
ClassificationHearing Aid, Air Conduction
Applicant ARGOSY ELECTRONICS 10300 WEST 70TH ST. P.O. BOX 59072 Eden Prairie,  MN  55344
ContactDavid A Preves
CorrespondentDavid A Preves
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 Received1994-08-22
Decision Date1994-10-12

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