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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor,physiological,patient(without arrhythmia detection or alarms)
510(k) Number K061590
Device Name SMDIE DEVICE INTERFACING SYSTEM
Original Applicant
SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT
2454 mcmullen booth road
suite 427
clearwater,  FL  33759
Original Contact ian gordon
Regulation Number870.2300
Classification Product Code
MWI  
Date Received06/08/2006
Decision Date 06/21/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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