DESKREM-1000

Calibrator, Hearing Aid / Earphone And Analysis Systems

STARKEY LABORATORIES, INC.

The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Deskrem-1000.

Pre-market Notification Details

Device IDK943459
510k NumberK943459
Device Name:DESKREM-1000
ClassificationCalibrator, Hearing Aid / Earphone And Analysis Systems
Applicant STARKEY LABORATORIES, INC. 6600 & 6700 WASHINGTON AVE SO Eden Prairie,  MN  55344
ContactRick Stromberg
CorrespondentRick Stromberg
STARKEY LABORATORIES, INC. 6600 & 6700 WASHINGTON AVE SO Eden Prairie,  MN  55344
Product CodeETW  
CFR Regulation Number874.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-18
Decision Date1994-10-21

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