Device Classification Name |
monitor, esophageal motility, anorectal motility, and tube
|
510(k) Number |
K013704 |
Device Name |
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER |
Applicant |
MEDIPLUS LTD. |
541 MORENO CIRCLE NE |
ST. PETERSBURG,
FL
33703
|
|
Applicant Contact |
ELIZABETH M PAUL |
Correspondent |
MEDIPLUS LTD. |
541 MORENO CIRCLE NE |
ST. PETERSBURG,
FL
33703
|
|
Correspondent Contact |
ELIZABETH M PAUL |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 11/08/2001 |
Decision Date | 08/05/2002 |
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
|
|
|