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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 K093422
Device Name VITAL SYNC MODEL 5000 SERIES
Original Applicant
SOMANETICS CORP.
1653 east maple rd.
troy,  MI  48083 -4208
Original Contact ronald a widman
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/03/2009
Decision Date 04/29/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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