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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, stationary
510(K) Number K120034
Model DF-211H
Device Name RADIOGRAPHIC X-RAY SYSTEM
Applicant
ORICH MEDICAL EQUIPMENT (TIANJIN CO., LTD.
6840 sw 45th ln #5
miami,  FL  33155
Contact jun peng
Regulation Number892.1680
Classification Product Code
KPR  
Date Received01/04/2012
Decision Date 04/17/2012
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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