Device Classification Name |
device, fertility diagnostic, contraceptive, software application
|
De Novo Number |
DEN170052 |
Device Name |
Natural Cycles |
Requester |
natural cycles nordic ab |
luntmakargatan 26 |
stockholm,
SE
111-37
|
|
Contact |
raoul scherwitzl |
|
Regulation Number | 884.5370
|
Classification Product Code |
|
Date Received | 09/20/2017 |
Decision Date | 08/10/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Obstetrics/Gynecology
|
Review Advisory Committee |
Obstetrics/Gynecology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|