QXY — Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature Class II
FDA product code QXY covers "Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature", a Class II medical device regulated under 21 CFR 870.1135. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QXY
- Device Class
- Class II
- Regulation Number
- 870.1135
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
An oscillometric-based, over-the-counter, atrial fibrillation notification feature is a software algorithm for analysis of signals from an oscillometric, non-invasive blood pressure measurement system to screen for possible atrial fibrillation in the device user.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230076 | omron healthcare | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature ( | October 8, 2024 |