QDB — Photoplethysmograph Analysis Software For Over-The-Counter Use Class II
FDA product code QDB covers "Photoplethysmograph Analysis Software For Over-The-Counter Use", a Class II medical device regulated under 21 CFR 870.2790. Submissions are reviewed by the Cardiovascular panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QDB
- Device Class
- Class II
- Regulation Number
- 870.2790
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231173 | apple | Irregular Rhythm Notification Feature (IRNF) | July 21, 2023 |
| K213971 | apple | Atrial Fibrillation History Feature | June 3, 2022 |
| K212372 | fitbit | Fitbit Irregular Rhythm Notifications | April 8, 2022 |
| K212516 | apple | IRNF App | October 22, 2021 |
| DEN180042 | apple | Irregular Rhythm Notification Feature | September 11, 2018 |