Device Classification Name |
endoscopic video imaging system/component, gastroenterology-urology
|
510(k) Number |
K853585 |
Device Name |
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS |
Applicant |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
TERRY J HARTL |
Correspondent |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Correspondent Contact |
TERRY J HARTL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/26/1985 |
Decision Date | 01/21/1986 |
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
|
|
|