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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
Device Name ACCUTORR V MONITOR, MODEL 0998-00-2000
Applicant
DATASCOPE CORP., PATIENT MONITORING DIVISION
800 MACARTHUR BLVD.
MAHWAH,  NJ  07430 -0619
Applicant Contact KATHLEEN KRAMER
Correspondent
DATASCOPE CORP., PATIENT MONITORING DIVISION
800 MACARTHUR BLVD.
MAHWAH,  NJ  07430 -0619
Correspondent Contact KATHLEEN KRAMER
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/14/2009
Decision Date 05/08/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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