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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K970061
Device Name ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)
Original Applicant
DATASCOPE CORP.
580 winters ave.
paramus,  NJ  07653
Original Contact frank casamssina
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/07/1997
Decision Date 09/25/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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