Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K192286 |
Device Name |
FUJIFILM EP-6000 Video Processor |
Applicant |
FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi |
Ashigarakami-Gun,
JP
258-8538
|
|
Applicant Contact |
Randy Vader |
Correspondent |
FujiFilm Medical Systems U.S.A., Inc. |
81 Hartwell Avenue |
Lexington,
MA
02421
|
|
Correspondent Contact |
Candace Alva |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/22/2019 |
Decision Date | 05/01/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|