RIONET HEARING AID

Hearing Aid, Master

KINDEL & ANDERSON

The following data is part of a premarket notification filed by Kindel & Anderson with the FDA for Rionet Hearing Aid.

Pre-market Notification Details

Device IDK802812
510k NumberK802812
Device Name:RIONET HEARING AID
ClassificationHearing Aid, Master
Applicant KINDEL & ANDERSON 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKHL  
CFR Regulation Number874.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-11-07
Decision Date1980-11-26

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