The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fuji Ec Id Camera.
Device ID | K932357 |
510k Number | K932357 |
Device Name: | FUJI EC ID CAMERA |
Classification | System, X-ray, Film Marking, Radiographic |
Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 333 LUDLOW ST. P.O. BOX 120035 Stamford, CT 06912 -0035 |
Contact | Robert Uzenoff |
Correspondent | Robert Uzenoff FUJIFILM MEDICAL SYSTEM U.S.A., INC. 333 LUDLOW ST. P.O. BOX 120035 Stamford, CT 06912 -0035 |
Product Code | JAC |
CFR Regulation Number | 892.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-14 |
Decision Date | 1993-07-26 |