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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, St Segment
510(k) Number K926099
Device Name DATASCOPE 6000 MONITOR
Applicant
Datascope Corp.
580 Winters Ave.
P.O. Box 5
Paramus,  NJ  07653
Applicant Contact MICHAEL BARILE
Correspondent
Datascope Corp.
580 Winters Ave.
P.O. Box 5
Paramus,  NJ  07653
Correspondent Contact MICHAEL BARILE
Regulation Number870.2340
Classification Product Code
MLC  
Date Received12/03/1992
Decision Date 08/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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