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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K091068
Model 0998-00-2000
Device Name ACCUTORR V MONITOR, MODEL 0998-00-2000
Original Applicant
800 macarthur blvd.
mahwah,  NJ  07430 0619
Original Contact kathleen kramer
Regulation Number870.1130
Classification Product Code
Date Received04/14/2009
Decision Date 05/08/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls