DAH/BERG MODEL HP BEHIND-THE-EAR HEARING AID

Hearing Aid, Air Conduction

MIRACLE-EAR/DAHLBERG, INC.

The following data is part of a premarket notification filed by Miracle-ear/dahlberg, Inc. with the FDA for Dah/berg Model Hp Behind-the-ear Hearing Aid.

Pre-market Notification Details

Device IDK852486
510k NumberK852486
Device Name:DAH/BERG MODEL HP BEHIND-THE-EAR HEARING AID
ClassificationHearing Aid, Air Conduction
Applicant MIRACLE-EAR/DAHLBERG, INC. 7731 COUNTRY CLUB DR. Golden Valley,  MN  55427
ContactJane E Hixson
CorrespondentJane E Hixson
MIRACLE-EAR/DAHLBERG, INC. 7731 COUNTRY CLUB DR. Golden Valley,  MN  55427
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-11
Decision Date1985-08-22

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