Device Classification Name |
photoplethysmograph analysis software for over-the-counter use
|
De Novo Number |
DEN180042 |
Device Name |
Irregular Rhythm Notification Feature |
Requester |
apple inc |
alexandria,
VA
22314
|
|
Contact |
donna-bea tillman |
|
Regulation Number | 870.2790
|
Classification Product Code |
|
Date Received | 08/09/2018 |
Decision Date | 09/11/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|