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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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K132038
Device Name ACCUTORR 7 VITAL SIGNS MONITOR
Applicant
Mindray North America
800 Macarthur Blvd.
Mahwh,  NJ  07430
Applicant Contact RUSSELL OLSEN
Correspondent
Mindray North America
800 Macarthur Blvd.
Mahwh,  NJ  07430
Correspondent Contact RUSSELL OLSEN
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/01/2013
Decision Date 05/02/2014
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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