Device Classification Name |
system, gastrointestinal motility (electrical)
|
510(k) Number |
K102801 |
Device Name |
PHTIP DISPOSABLE ISFET CATHETER |
Applicant |
E-CATH CO., LTD |
13605 WEST 7TH AVENUE |
GOLDEN,
CO
80401
|
|
Applicant Contact |
ROBERT N CLARK |
Correspondent |
E-CATH CO., LTD |
13605 WEST 7TH AVENUE |
GOLDEN,
CO
80401
|
|
Correspondent Contact |
ROBERT N CLARK |
Regulation Number | 876.1725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/27/2010 |
Decision Date | 10/26/2010 |
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
|
|
|