FDA.reportPublic FDA data

De Novo 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))
Contact
terri ingalls
De Novo number
DEN230076
Product code
QXY
Regulation
870.1135
Classification name
oscillometric-based, over-the-counter, atrial fibrillation notification feature
Decision
granted (DENG)
Decision date
2024-10-08
Date received
2023-11-13
Classification advisory
Cardiovascular
Review advisory
Cardiovascular
Type
Direct

Current FDA Classification#

Product code
QXY
Device name
Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature
Medical specialty
Cardiovascular
Device class
2
Regulation
870.1135
Implant
N
Life sustain/support
N