Device Classification Name |
Endoscope, Accessories, Image Post-Processing For Color Enhancement
|
510(k) Number |
K122470 |
Device Name |
PENTAX EPK-I5010 VIDEO PROCESSOR |
Applicant |
PENTAX MEDICAL |
3 PARAGON DRIVE |
MONTVALE,
NJ
07645
|
|
Applicant Contact |
KRISHNA GOVINDARAJAN |
Correspondent |
PENTAX MEDICAL |
3 PARAGON DRIVE |
MONTVALE,
NJ
07645
|
|
Correspondent Contact |
KRISHNA GOVINDARAJAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/13/2012 |
Decision Date | 04/10/2013 |
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
|
|
|