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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 K053462
Device Name 3160 MRI PATIENT MONITORING SYSTEM
Applicant
Invivo Corporation
12601 Research Pkwy.
Orlando,  FL  32826
Applicant Contact NEIL BATTISTE
Correspondent
Invivo Corporation
12601 Research Pkwy.
Orlando,  FL  32826
Correspondent Contact NEIL BATTISTE
Regulation Number870.2300
Classification Product Code
MWI  
Date Received12/13/2005
Decision Date 01/18/2006
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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