MODEL UC SPECTRUM IN-THE-CANAL 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 Model Uc Spectrum In-the-canal Hearing Aid.

Pre-market Notification Details

Device IDK862104
510k NumberK862104
Device Name:MODEL UC SPECTRUM IN-THE-CANAL HEARING AID
ClassificationHearing Aid, Air Conduction
Applicant MIRACLE-EAR/DAHLBERG, INC. 7731 COUNTRY CLUB DR. Golden Valley,  MN  55427
ContactRobert E Meyer
CorrespondentRobert E Meyer
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 Received1986-06-02
Decision Date1986-06-23

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