Device Classification Name |
endoscopic ultrasound system, gastroenterology-urology
|
510(k) Number |
K130247 |
Device Name |
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS |
Applicant |
PENTAX OF AMERICA, INC. |
3 PARAGON DRIVE |
MONTVALE,
NJ
07645
|
|
Applicant Contact |
KRISHNA GOVINDARAJAN |
Correspondent |
PENTAX OF AMERICA, INC. |
3 PARAGON DRIVE |
MONTVALE,
NJ
07645
|
|
Correspondent Contact |
KRISHNA GOVINDARAJAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/01/2013 |
Decision Date | 03/20/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|