DEN230076 is an FDA 510(k) submission for the Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)). This device is classified as a Oscillometric-based, Over-the-counter, Atrial Fibrillation Notification Feature (Class II - Special Controls, product code QXY).
Submitted by Omron Healthcare, Inc. (Hoffman Estates, US). The FDA issued a Not Cleared (DENG) decision on October 8, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1135. 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..
| 510(k) Number | DEN230076 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 13, 2023 |
| Decision Date | October 08, 2024 |
| Days to Decision | 330 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | QXY — Oscillometric-based, Over-the-counter, Atrial Fibrillation Notification Feature |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1135 |
| 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. |