K212516 is an FDA 510(k) clearance for the IRNF App. 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 October 22, 2021, 73 days after receiving the submission on August 10, 2021.
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 | K212516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2021 |
| Decision Date | October 22, 2021 |
| Days to Decision | 73 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. |