Device Classification Name |
esophageal, mucosal, electrical characterization
|
De Novo Number |
DEN180067 |
Device Name |
Mucosal Integrity Conductivity (MI) Test System |
Requester |
diversatek healthcare inc. |
9150 commerce center circle, suite 500 |
highlands ranch,
CO
80129
|
|
Contact |
laura l boll |
|
Regulation Number | 876.1450
|
Classification Product Code |
|
Date Received | 12/17/2018 |
Decision Date | 12/23/2019 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Gastroenterology/Urology
|
Review Advisory Committee |
Gastroenterology/Urology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|