Device Classification Name |
gastroscope and accessories, flexible/rigid
|
510(k) Number |
K181763 |
Device Name |
FUJIFILM Ultrasonic Endoscope |
Applicant |
FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi |
Ashigarakami-Gun,
JP
258-8538
|
|
Applicant Contact |
Randy Vader |
Correspondent |
FUJIFILM Medical Systems U.S.A., Inc. |
10 High Point Drive |
Wayne,
NJ
07470
|
|
Correspondent Contact |
Jeffrey Wan |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/03/2018 |
Decision Date | 07/27/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|