Class Class II

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)) (DEN230076)

DEN230076 2024-10-08 Direct
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Description

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)) by Omron Healthcare, Inc., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberDEN230076
Clearance Date2024-10-08
Clearance TypeDirect
Product CodeQXY
Regulation Number870.1135

FDA Database

View on FDA Database

Categories

Cardiovascular

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