FUJI MEDICAL DRY IMAGER FM-DP 2636

Camera, Multi Format, Radiological

FUJIFILM MEDICAL SYSTEM U.S.A., INC.

The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fuji Medical Dry Imager Fm-dp 2636.

Pre-market Notification Details

Device IDK962967
510k NumberK962967
Device Name:FUJI MEDICAL DRY IMAGER FM-DP 2636
ClassificationCamera, Multi Format, Radiological
Applicant FUJIFILM MEDICAL SYSTEM U.S.A., INC. 333 LUDLOW ST. P.O. BOX 120035 Stamford,  CT  06912 -0035
ContactRobert A Uzenoff
CorrespondentRobert A Uzenoff
FUJIFILM MEDICAL SYSTEM U.S.A., INC. 333 LUDLOW ST. P.O. BOX 120035 Stamford,  CT  06912 -0035
Product CodeLMC  
CFR Regulation Number892.2040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-30
Decision Date1996-10-28
Summary:summary

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