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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K993531
Device Name PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
Applicant
Datascope Corp.
580 Winters Ave.
Paramus,  NJ  07652
Applicant Contact SUSAN E MANDY
Correspondent
Datascope Corp.
580 Winters Ave.
Paramus,  NJ  07652
Correspondent Contact SUSAN E MANDY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received10/18/1999
Decision Date 01/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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