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))
FDA 510(k) clearance DEN230076 · decided 2024-10-08
Clearance details
- 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.
- Decision
- Unknown
- Date received
- 2023-11-13
- Decision date
- 2024-10-08
- Days to decision
- 330 days
- Clearance type
- Direct
- Product code
- QXY
- Device class
- 2
- Regulation number
- 870.1135
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hoffman Estates, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.