K231173 is an FDA 510(k) clearance for the Irregular Rhythm Notification Feature (IRNF). This device is classified as a Photoplethysmograph Analysis Software For Over-the-counter Use (Class II - Special Controls, product code QDB).
Submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on July 21, 2023, 87 days after receiving the submission on April 25, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2790. A Photoplethysmograph Analysis Software Device For Over-the-counter Use Analyzes Photoplethysmograph Data And Provides Information For Identifying Irregular Heart Rhythms. This Device Is Not Intended To Provide A Diagnosis..
| 510(k) Number | K231173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2023 |
| Decision Date | July 21, 2023 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QDB - Photoplethysmograph Analysis Software For Over-the-counter Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2790 |
| Definition | A Photoplethysmograph Analysis Software Device For Over-the-counter Use Analyzes Photoplethysmograph Data And Provides Information For Identifying Irregular Heart Rhythms. This Device Is Not Intended To Provide A Diagnosis. |