FDA 510(k) Application Details - K132173

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K132173
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant SANITAS, INC.
11440 W. BERNARDO COURT, STE 300
SAN DIEGO, CA 92027 US
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Contact ALAN DONALD
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 07/15/2013
Decision Date 05/30/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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