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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K883254
Device Name MULTINEX MONITOR (MODIFICATION)
Applicant
Datascope Corp.
Winters Ave.
P.O. Box 5
Paramus,  NJ  07653
Applicant Contact ARTHUR FRIEDMAN
Correspondent
Datascope Corp.
Winters Ave.
P.O. Box 5
Paramus,  NJ  07653
Correspondent Contact ARTHUR FRIEDMAN
Regulation Number868.1720
Classification Product Code
CCL  
Date Received08/02/1988
Decision Date 09/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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