FDA 510(k) Application Details - K100939

Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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510(K) Number K100939
Device Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
HEWLETT-PACKARD STR.2
BOEBLINGEN D 71034 DE
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Contact ANDREAS SUCHI
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Regulation Number 870.1025

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Classification Product Code MHX
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Date Received 04/05/2010
Decision Date 04/30/2010
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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