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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 K152330
Device Name Expression MR400 MRI Patient Monitoring System
Applicant
Invivo Corporation
12151 Research Pkwy., Suite 200
Orlando,  FL  32826
Applicant Contact Rusty Kelly
Correspondent
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01801
Correspondent Contact Christine Trefethen
Regulation Number870.2300
Classification Product Code
MWI  
Date Received08/18/2015
Decision Date 12/23/2015
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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