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FDA 510(k) Application Details - K040955
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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510(K) Number
K040955
Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
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DAVID OSBORN
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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
04/13/2004
Decision Date
05/12/2004
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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