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FDA 510(k) Application Details - K142514
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K142514
Device Name
System, Image Processing, Radiological
Applicant
EBM Technologies Incorporated
5F., No. 516, Sec. 1, Neihu Rd., Neihu Dist.
Taipei TW
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Contact
John Su
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/08/2014
Decision Date
12/18/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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