FDA 510(k) Application Details - K080091

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K080091
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant HEALTH HERO NETWORK, INC.
2400 GENG ROAD
SUITE 200
PALO ALTO, CA 94303 US
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Contact ROBIN BUSH SAWAMURA
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 01/14/2008
Decision Date 02/05/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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