510(k) DEN230076
- Device
- 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.
- 510(k) number
- DEN230076
- Product code
- QXY
- Decision
- Unknown (DENG)
- Decision date
- 2024-10-08
- Date received
- 2023-11-13
- Regulation
- 870.1135
- Classification name
- Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Terri Ingalls
- Address
- 2895 Greenspoint Pkwy. Suite 100 Hoffman Estates IL US 60169 60169
FDA Registration Numbers#
- 3006852037
- 1450057
- 8030245
Source Documents#
510(k) summary PDF not indicated by FDA