The following data is part of a De Novo classification by Apple Inc with the FDA for Irregular Rhythm Notification Feature.
| DeNovo ID | DEN180042 |
| Device Name: | Irregular Rhythm Notification Feature |
| Classification | Photoplethysmograph Analysis Software For Over-the-counter Use |
| Applicant | Apple Inc Alexandria, VA 22314 |
| Contact | Donna-bea Tillman |
| Product Code | QDB |
| CFR Regulation Number | 870.2790 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Cardiovascular |
| Classification Advisory | Cardiovascular |
| Type | Direct |
| Date Received | 2018-08-09 |
| Decision Date | 2018-09-11 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190198909527 | DEN180042 | 000 |
| 00190198909510 | DEN180042 | 000 |