Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K954451 |
Device Name |
EVIS 140 SYSTEM |
Applicant |
OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Applicant Contact |
BARRY E SANDA |
Correspondent |
OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Correspondent Contact |
BARRY E SANDA |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/25/1995 |
Decision Date | 03/29/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|