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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 K131382
Device Name EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL
Applicant
Invivo Corporation
12151 Research Pkwy.
Orlando,  FL  32826
Applicant Contact RUSTY KELLY
Correspondent
Invivo Corporation
12151 Research Pkwy.
Orlando,  FL  32826
Correspondent Contact RUSTY KELLY
Regulation Number870.2300
Classification Product Code
MWI  
Date Received05/14/2013
Decision Date 07/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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