Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K944759 |
Device Name |
200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM |
Applicant |
FUJINON, INC. |
10 HIGH POINT DR. |
WAYNE,
NJ
07470
|
|
Applicant Contact |
H J EVANS |
Correspondent |
FUJINON, INC. |
10 HIGH POINT DR. |
WAYNE,
NJ
07470
|
|
Correspondent Contact |
H J EVANS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/27/1994 |
Decision Date | 04/11/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|