BEHIND THE EAR HEARING AID

Hearing Aid, Air Conduction

AUDINA HEARING INSTRUMENT

The following data is part of a premarket notification filed by Audina Hearing Instrument with the FDA for Behind The Ear Hearing Aid.

Pre-market Notification Details

Device IDK936190
510k NumberK936190
Device Name:BEHIND THE EAR HEARING AID
ClassificationHearing Aid, Air Conduction
Applicant AUDINA HEARING INSTRUMENT 150 E WILDMERE ST. P.O. BOX 877 Casselberry,  FL  32750
ContactFrank J Robilotta
CorrespondentFrank J Robilotta
AUDINA HEARING INSTRUMENT 150 E WILDMERE ST. P.O. BOX 877 Casselberry,  FL  32750
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-27
Decision Date1994-04-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.