FDA 510(k) Application Details - K120895

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K120895
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant INTOUCH HEALTH, INC.
6330 HOLLISTER AVE.
GOLETA, CA 93117 US
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Contact STEVE SIDWELL
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 03/23/2012
Decision Date 05/24/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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