Device Classification Name |
endoscopic video imaging system/component, gastroenterology-urology
|
510(k) Number |
K201200 |
Device Name |
Visera Elite II Video System Center |
Applicant |
Olympus Medical Systems Corp. |
2951 Ishikawa-cho |
Hachioji-shi,
JP
192-8507
|
|
Applicant Contact |
Toshiyuki Nakajima |
Correspondent |
Olympus Corporation of the Americas |
3500 Corporate Parkway PO Box 610 |
Center Valley,
PA
18034 -0610
|
|
Correspondent Contact |
Lisa M. Boyle |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/04/2020 |
Decision Date | 07/22/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|