FDA 510(k) Application Details - K140852

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K140852
Device Name System,Network And Communication,Physiological Monitors
Applicant VECTRACOR, INC
785 TOTOWA ROAD
SUITE, 100
TOTOWA, NJ 07512 US
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Contact BRAD S SCHRECK
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 04/03/2014
Decision Date 01/30/2015
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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