510(k) DEN180042
- Device
- Irregular Rhythm Notification Feature
- Applicant
- Apple, Inc.
- 510(k) number
- DEN180042
- Product code
- QDB
- Decision
- Unknown (DENG)
- Decision date
- 2018-09-11
- Date received
- 2018-08-09
- Regulation
- 870.2790
- Classification name
- Photoplethysmograph Analysis Software For Over-The-Counter Use
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Donna-Bea Tillman
- Address
- Alexandria VA US 22314 22314
FDA Registration Numbers#
- 3014343954
- 3009253624
- 3017616353
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QDB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231173 | Irregular Rhythm Notification Feature (IRNF) | Apple, Inc. | 2023-07-21 |
| K213971 | Atrial Fibrillation History Feature | Apple, Inc. | 2022-06-03 |
| K212372 | Fitbit Irregular Rhythm Notifications | Fitbit, Inc. | 2022-04-08 |
| K212516 | IRNF App | Apple, Inc. | 2021-10-22 |