FDA 510(k) Application Details - K071564

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K071564
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
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Contact RICK SCHUL
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 06/07/2007
Decision Date 08/31/2007
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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