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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 K842538
Device Name ACCUTORR CSM SYSTEM
Applicant
DATASCOPE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DATASCOPE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/28/1984
Decision Date 03/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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