TINNITUS MASKER

Masker, Tinnitus

STARKEY LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK781798
510k NumberK781798
Device Name:TINNITUS MASKER
ClassificationMasker, Tinnitus
Applicant STARKEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKLW  
CFR Regulation Number874.3400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-10-23
Decision Date1978-11-03

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