HEARING AID G3H & G3T

Hearing Aid, Air Conduction

WIDEX HEARING AID CO., INC.

The following data is part of a premarket notification filed by Widex Hearing Aid Co., Inc. with the FDA for Hearing Aid G3h & G3t.

Pre-market Notification Details

Device IDK832129
510k NumberK832129
Device Name:HEARING AID G3H & G3T
ClassificationHearing Aid, Air Conduction
Applicant WIDEX HEARING AID CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-01
Decision Date1983-07-26

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