U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID

Hearing Aid, Air Conduction

RICHARDS MEDICAL CO., INC.

The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for U-impulse Air Conduction In-the-canal Hearing Aid.

Pre-market Notification Details

Device IDK873560
510k NumberK873560
Device Name:U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID
ClassificationHearing Aid, Air Conduction
Applicant RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactRobert F Games
CorrespondentRobert F Games
RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-02
Decision Date1987-09-29

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