Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K113873 |
Device Name |
PENTAX EPK-I5020 VIDEO PROCESSOR |
Applicant |
PENTAX OF AMERICA, INC. |
1129 BLOOMFIELD AVENUE |
WEST CALDWELL,
NJ
07006
|
|
Applicant Contact |
ROBERT SCHIFF |
Correspondent |
PENTAX OF AMERICA, INC. |
1129 BLOOMFIELD AVENUE |
WEST CALDWELL,
NJ
07006
|
|
Correspondent Contact |
ROBERT SCHIFF |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/30/2011 |
Decision Date | 06/22/2012 |
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
|
|
|