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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
Applicant
SOMANETICS CORP.
1653 EAST MAPLE RD.
TROY,  MI  48083 -4208
Applicant Contact RONALD A WIDMAN
Correspondent
SOMANETICS CORP.
1653 EAST MAPLE RD.
TROY,  MI  48083 -4208
Correspondent 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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