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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K143396
Device Name omni TRAX Active Patient Tracker
Applicant
Civco Medical Instruments CO Inc Dba Civco Medical Solutions
102 First St. S.
Kalona,  IA  52247
Applicant Contact Amanda Stahle
Correspondent
Civco Medical Instruments CO Inc Dba Civco Medical Solutions
102 First St. S.
Kalona,  IA  52247
Correspondent Contact Amanda Stable
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
LNH  
Date Received11/26/2014
Decision Date 01/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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