Multiflex Tinnitus Technology

Masker, Tinnitus

Starkey Laboratories, Inc.

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

Pre-market Notification Details

Device IDK201370
510k NumberK201370
Device Name:Multiflex Tinnitus Technology
ClassificationMasker, Tinnitus
Applicant Starkey Laboratories, Inc. 6700 Washington Ave S Eden Prairie,  MN  55344
ContactKa Zoua Xiong
CorrespondentKa Zoua Xiong
Starkey Laboratories, Inc. 6700 Washington Ave S Eden Prairie,  MN  55344
Product CodeKLW  
CFR Regulation Number874.3400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-22
Decision Date2020-06-19

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