FDA 510(k) Application Details - K151834

Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning

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510(K) Number K151834
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant BEMER Int. AG
Austrasse 15
Triesen 9495 LI
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Contact Sven Bieler
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 07/06/2015
Decision Date 02/22/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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