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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)
Applicant
DATASCOPE CORP.
580 WINTERS AVE.
PARAMUS,  NJ  07653
Applicant Contact FRANK CASAMSSINA
Correspondent
DATASCOPE CORP.
580 WINTERS AVE.
PARAMUS,  NJ  07653
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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