Device Classification Name |
pressure ulcer management tool
|
De Novo Number |
DEN170021 |
Device Name |
SEM Scanner (Model 200) |
Requester |
bruin biometrics, llc |
10960 wilshire blvd, suite 950 |
los angeles,
CA
90024
|
|
Contact |
ya-chen tonar |
|
Regulation Number | 876.2100
|
Classification Product Code |
|
Date Received | 04/03/2017 |
Decision Date | 12/20/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Gastroenterology/Urology
|
Review Advisory Committee |
Gastroenterology/Urology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|