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510(k) K131382

EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL by Invivo Corporation — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2013
Date Received
May 14, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

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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