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FDA 510(k) Application Details - K962967
Device Classification Name
Camera, Multi Format, Radiological
More FDA Info for this Device
510(K) Number
K962967
Device Name
Camera, Multi Format, Radiological
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
333 LUDLOW ST.
P.O. BOX 120035
STAMFORD, CT 06912-0035 US
Other 510(k) Applications for this Company
Contact
ROBERT A UZENOFF
Other 510(k) Applications for this Contact
Regulation Number
892.2040
More FDA Info for this Regulation Number
Classification Product Code
LMC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/30/1996
Decision Date
10/28/1996
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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