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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 K863855
Device Name ACCUSAT
Applicant
Datascope Corp.
580 Winters Ave.
P.O. Box 5
Paramus,  NJ  07653
Applicant Contact ARTHUR FRIEDMAN
Correspondent
Datascope Corp.
580 Winters Ave.
P.O. Box 5
Paramus,  NJ  07653
Correspondent Contact ARTHUR FRIEDMAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/02/1986
Decision Date 01/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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