5 devices · 1 company · 2021 to 2025
Apple Inc.: AI-enabled devices on FDA's list
5 devices from Apple Inc., 2021 to 2025, from 1 company across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 5 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Apple Inc.
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Hypertension Notification FeatureK250507 · 510(k) | Cardiovascular | SFR | database entry | |
| Sleep Apnea Notification FeatureK240929 · 510(k) | Anesthesiology | QZW | database entry | |
| Irregular Rhythm Notification FeatureK231173 · 510(k) | Cardiovascular | QDB | database entry | |
| Atrial Fibrillation History FeatureK213971 · 510(k) | Cardiovascular | QDB | database entry | |
| IRNF AppK212516 · 510(k) | Cardiovascular | QDB | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.