Device Classification Name |
fetal head elevator
|
De Novo Number |
DEN150053 |
Device Name |
FETAL PILLOW |
Requester |
safe obstetric systems ltd |
berkeley townsend 150 hutton road |
shenfield,
GB
cm15 8nl
|
|
Contact |
rajiv varma |
|
Regulation Number | 884.4350
|
Classification Product Code |
|
Date Received | 11/18/2015 |
Decision Date | 07/27/2017 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Obstetrics/Gynecology
|
Review Advisory Committee |
Obstetrics/Gynecology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|