DEN230076
- 510(k) number
- DEN230076
- Device name
- Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))
- Applicant
- Omron Healthcare, Inc. IL · US
- Product code
- QXY — Oscillometric-Based, Over-The-Counter, Atrial Fibril
- Decision date
- 2024-10-08
- Date received
- 2023-11-13
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Cardiovascular
Official FDA record: DEN230076
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.