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510(k) K103700

ESSENTIAL MRI PATIENT MONITOR by Invivo Corporation — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2011
Date Received
December 20, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

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