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FDA 510(k) Application Details - K061590
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MWI
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More FDA Info for this Product Code
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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