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510(k) K143396

omni TRAX Active Patient Tracker by Civco Medical Instruments CO Inc Dba Civco Medical Solutions — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2015
Date Received
November 26, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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