BTL-703-2

Stimulator, Muscle, Powered, For Muscle Conditioning

BTL

The following data is part of a premarket notification filed by Btl with the FDA for Btl-703-2.

Pre-market Notification Details

Device IDK200382
510k NumberK200382
Device Name:BTL-703-2
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant BTL 362 Elm Street Marlborough,  MA  01752
ContactDavid Chmel
CorrespondentDavid Chmel
BTL 362 Elm Street Marlborough,  MA  01752
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-18
Decision Date2021-01-06

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