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FDA 510(k) Application Details - K120034
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K120034
Device Name
System, X-Ray, Stationary
Applicant
ORICH MEDICAL EQUIPMENT (TIANJIN CO., LTD.
6840 SW 45TH LN #5
MIAMI, FL 33155 US
Other 510(k) Applications for this Company
Contact
JUN PENG
Other 510(k) Applications for this Contact
Regulation Number
892.1680
More FDA Info for this Regulation Number
Classification Product Code
KPR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/04/2012
Decision Date
04/17/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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