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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 K090785
Device Name MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214
Applicant
Invivo Corp.
12501 Research Pkwy.
Orlando,  FL  32826
Applicant Contact RUSTY KELLY
Correspondent
Invivo Corp.
12501 Research Pkwy.
Orlando,  FL  32826
Correspondent Contact RUSTY KELLY
Regulation Number870.2300
Classification Product Code
MWI  
Date Received03/23/2009
Decision Date 12/15/2009
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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