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FDA 510(k) Application Details - K072070
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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510(K) Number
K072070
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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MARKUS STACHA
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Regulation Number
870.1025
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Classification Product Code
MHX
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Date Received
07/30/2007
Decision Date
08/10/2007
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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