510(k) K213971
- Device
- Atrial Fibrillation History Feature
- Applicant
- Apple Inc.
- 510(k) number
- K213971
- Product code
- QDB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-03
- Date received
- 2021-12-20
- Regulation
- 870.2790
- Classification name
- Photoplethysmograph Analysis Software For Over-the-counter Use
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Luke Olson
- Address
- 1 Apple Park Way Cupertino CA US 95014 95014
FDA Registration Numbers#
- 3009253624
- 3014343954
- 3017616353
Source Documents#
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 |
| K212372 | Fitbit Irregular Rhythm Notifications | Fitbit, Inc. | 2022-04-08 |
| K212516 | IRNF App | Apple, Inc. | 2021-10-22 |
| DEN180042 | Irregular Rhythm Notification Feature | Apple, Inc. | 2018-09-11 |
Legacy Summary#
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FDA Review#
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