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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 K031760
Device Name VIEWPOINT TELEMETRY SYSTEM
Applicant
DATASCOPE CORP.
800 MACARTHUR BLVD.
MAHWAH,  NJ  07430 -0619
Applicant Contact SUSAN E MANDY
Correspondent
DATASCOPE CORP.
800 MACARTHUR BLVD.
MAHWAH,  NJ  07430 -0619
Correspondent Contact SUSAN E MANDY
Regulation Number870.1025
Classification Product Code
MHX  
Date Received06/06/2003
Decision Date 10/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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