Cardiology
IRNF App
Apple Inc.
FDA-cleared AI medical device
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.
FDA Submission Metadata
- Submission number
- K212516
- Decision date
- October 2021
- FDA panel
- Cardiovascular
- Product code
- QDB
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.