FDA 510(k) Application Details - K030731

Device Classification Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

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510(K) Number K030731
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant PHILIPS MEDICAL SYSTEMS, INC.
HEWLETT PACKARD STR. 2
BOBLINGEN D71034 DE
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Contact HERBERT VAN DYK
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 03/10/2003
Decision Date 03/21/2003
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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