STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID

Hearing Aid, Air Conduction

STARKEY LABORATORIES, INC.

The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Star 42 Pp Sp Star 42 Digitally Programmable Hearing Aid.

Pre-market Notification Details

Device IDK942594
510k NumberK942594
Device Name:STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID
ClassificationHearing Aid, Air Conduction
Applicant STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SO. Eden Prairie,  MN  55344
ContactRick Stromberg
CorrespondentRick Stromberg
STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SO. Eden Prairie,  MN  55344
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-01
Decision Date1994-07-05

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