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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 K102004
Device Name ENDEAVOUR MONITORING SYSTEM
Applicant
MINDRAY DS USA, INC.
800 MACARTHUR BLVD
MAHWAH,  NJ  07430
Applicant Contact RUSSELL OLSEN
Correspondent
MINDRAY DS USA, INC.
800 MACARTHUR BLVD
MAHWAH,  NJ  07430
Correspondent Contact RUSSELL OLSEN
Regulation Number870.1025
Classification Product Code
MHX  
Date Received07/15/2010
Decision Date 09/10/2010
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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