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510(k) K124061

MRI PATIENT MONITORING SYSTEM (MODEL 865214) by Invivo Corporation — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2013
Date Received
December 31, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

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