FDA 510(k) Application Details - K091176

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K091176
Device Name System,Network And Communication,Physiological Monitors
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
M/S 0220
ANDOVER, MA 01810 US
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Contact PAUL SCHRADER
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 04/22/2009
Decision Date 11/13/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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