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510(k) K123902

PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) by Oktx, LLC — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2013
Date Received
December 18, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type

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