Device Classification Name |
oropharyngeal electrical stimulator
|
De Novo Number |
DEN220025 |
Device Name |
Phagenyx System |
Requester |
phagenesis limited |
unit 18, enterprise house |
pencroft ay, manchester science park |
manchester,
GB
m15 65e
|
|
Contact |
conor mulrooney |
|
Regulation Number | 874.5950
|
Classification Product Code |
|
Date Received | 04/19/2022 |
Decision Date | 09/16/2022 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Ear Nose & Throat
|
Review Advisory Committee |
Ear Nose & Throat
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|