MIRACLE-EAR WITH POWER CIRCUIT OPTION

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 Miracle-ear With Power Circuit Option.

Pre-market Notification Details

Device IDK935962
510k NumberK935962
Device Name:MIRACLE-EAR WITH POWER CIRCUIT OPTION
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 Received1993-12-13
Decision Date1994-05-04

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