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FDA 510(k) Application Details - K052801
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K052801
Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR.2
BOEBLINGEN D 71034 DE
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HAUKE SCHIK
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Regulation Number
870.1025
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Classification Product Code
MHX
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More FDA Info for this Product Code
Date Received
10/03/2005
Decision Date
11/02/2005
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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