Cupertino, CA, US · 10 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | Class II | Cardiovascular | 3 | 2023-07-21 |
| SCW | Digital Prismatic Correction | Class I | Ophthalmic | 2 | 2025-06-23 |
| SHN | Calibration Software For Radiology Displays | Class I | Radiology | 1 | 2026-04-01 |
| SFR | Hypertension Machine Learning-Based Notification Software | Class II | Cardiovascular | 1 | 2025-09-11 |
| QZW | Over-The-Counter Device To Assess Risk Of Sleep Apnea | Class II | Anesthesiology | 1 | 2024-09-13 |
| SCR | Air-Conduction Hearing Aid Software | Class II | Ear, Nose, Throat | 1 | 2024-09-12 |
| QDA | Electrocardiograph Software For Over-The-Counter Use | Class II | Cardiovascular | 1 | 2020-10-08 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-01 | K253582 | Medical Imaging Calibration Feature (MICF) | SHN | Class I | Radiology |
| 2025-09-11 | K250507 | Hypertension Notification Feature (HTNF) | SFR | Class II | Cardiovascular |
| 2025-06-23 | K250143 | Digital Prism Correction Feature (DPCF) | SCW | Class I | Ophthalmic |
| 2024-10-21 | K242058 | Digital Prism Correction Feature (DPCF) | SCW | Class I | Ophthalmic |
| 2024-09-13 | K240929 | Sleep Apnea Notification Feature (SANF) | QZW | Class II | Anesthesiology |
| 2024-09-12 | DEN230081 | Hearing Aid Feature (HAF) | SCR | Class II | Ear, Nose, Throat |
| 2023-07-21 | K231173 | Irregular Rhythm Notification Feature (IRNF) | QDB | Class II | Cardiovascular |
| 2022-06-03 | K213971 | Atrial Fibrillation History Feature | QDB | Class II | Cardiovascular |
| 2021-10-22 | K212516 | IRNF App | QDB | Class II | Cardiovascular |
| 2020-10-08 | K201525 | ECG App | QDA | Class II | Cardiovascular |