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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K062098
Device Name SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX
Applicant
Datascope Corp.
800 Macarthur Blvd.
Mahwh,  NJ  07430
Applicant Contact KATHLEEN KRAMER
Correspondent
Datascope Corp.
800 Macarthur Blvd.
Mahwh,  NJ  07430
Correspondent Contact KATHLEEN KRAMER
Regulation Number870.1025
Classification Product Code
MHX  
Date Received07/24/2006
Decision Date 02/05/2007
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
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