Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K202646 |
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 Surgical Technologies of America |
118 Turnpike Road, Suite 120 |
Southborough,
MA
01772
|
|
Correspondent Contact |
Anne-Marie Keefe |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/11/2020 |
Decision Date | 10/29/2020 |
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
|
|
|