Clearance Summary
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)) received FDA 510(k) clearance under submission number DEN230076, sponsored by Omron Healthcare, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-10-08.
- Submission: DEN230076
- Applicant / Sponsor: Omron Healthcare, Inc.
- Clearance pathway: Direct
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1135
- Decision date: 2024-10-08
Classification & Regulation
This clearance is catalogued under FDA product code QXY and 21 CFR 870.1135, within the Cardiovascular review panel as a Class II device.