DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT

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 Dahlberg Hearing Aid With Multi-channel Compression Circuit.

Pre-market Notification Details

Device IDK964530
510k NumberK964530
Device Name:DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT
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 Received1996-11-12
Decision Date1996-11-27
Summary:summary

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