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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, mobile
510(k) Number K122298
Device Name AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR
Original Applicant
AJEX MEDITECH., LTD
52 newtown plaza
plainview,  NY  11803
Original Contact william little
Regulation Number892.1720
Classification Product Code
IZL  
Date Received07/31/2012
Decision Date 03/28/2014
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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