FDA 510(k) Application Details - K150742

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K150742
Device Name Stimulator, Muscle, Powered
Applicant NIVEUS MEDICAL, INC.
849 Independence Avenue Suite C
Mountain View, CA 94043 US
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Contact Brian Fahey
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 03/23/2015
Decision Date 07/23/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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