FDA 510(k) Application Details - K061590

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

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510(K) Number K061590
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT
2454 MCMULLEN BOOTH ROAD
SUITE 427
CLEARWATER, FL 33759 US
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Contact IAN GORDON
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 06/08/2006
Decision Date 06/21/2006
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 Y
Expedited Review



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