AUDIOTONE (A554H)

Hearing Aid, Air Conduction

MIRACLE-EAR, INC.

The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Audiotone (a554h).

Pre-market Notification Details

Device IDK965057
510k NumberK965057
Device Name:AUDIOTONE (A554H)
ClassificationHearing Aid, Air Conduction
Applicant MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley,  MN  55422
ContactMelanie Raska
CorrespondentMelanie Raska
MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley,  MN  55422
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-18
Decision Date1997-01-27
Summary:summary

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