Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K971373 |
Device Name |
VISTA SINGLE CHIP VIDEO CAMERA |
Applicant |
VISTA MEDICAL TECHNOLOGIES, INC. |
134 FLANDERS RD. |
WESTBOROUGH,
MA
01581
|
|
Applicant Contact |
MARTIN NEWMAN |
Correspondent |
VISTA MEDICAL TECHNOLOGIES, INC. |
134 FLANDERS RD. |
WESTBOROUGH,
MA
01581
|
|
Correspondent Contact |
MARTIN NEWMAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/14/1997 |
Decision Date | 05/20/1997 |
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
|
Recalls |
CDRH Recalls
|
|
|