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FDA 510(k) Application Details - K142773
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K142773
Device Name
System, X-Ray, Stationary
Applicant
EOS IMAGING
10 RUE MERCOEUR
PARIS F-75011 FR
Other 510(k) Applications for this Company
Contact
Karine Chevrie
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
09/25/2014
Decision Date
01/22/2015
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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