Device Classification Name |
insufflator, automatic carbon-dioxide for endoscope
|
510(k) Number |
K180711 |
Device Name |
FUJIFILM Endoscopic CO2 Regulator GW-100 |
Applicant |
FUJIFILM Corporation |
798 Miyanodai Kaisei-Machi |
Ashigarakami-Gun,
JP
258-8538
|
|
Applicant Contact |
Randy Vader |
Correspondent |
FUJIFILM Medical Systems U.S.A., Inc. |
40 Boroline Road |
Allendale,
NJ
07401
|
|
Correspondent Contact |
Jeffrey Wan |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/19/2018 |
Decision Date | 05/25/2018 |
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
|
|
|