SOUNDCHOICE K-AMP

Hearing Aid, Air Conduction

BAUSCH & LOMB, INC.

The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Soundchoice K-amp.

Pre-market Notification Details

Device IDK923735
510k NumberK923735
Device Name:SOUNDCHOICE K-AMP
ClassificationHearing Aid, Air Conduction
Applicant BAUSCH & LOMB, INC. 7555 MARKET PLACE DR. Eden Prairie,  MN  55344
ContactTerrence Martin
CorrespondentTerrence Martin
BAUSCH & LOMB, INC. 7555 MARKET PLACE DR. Eden Prairie,  MN  55344
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-27
Decision Date1992-09-28

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