Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)) +1 more— 510(k) DEN230076

Name: FDA 510(k) clearance DEN230076
Creator: U.S. Food and Drug Administration
Published: 2024-10-08

Unknown

Omron Healthcare, Inc.

FDA 510(k) clearance DEN230076 for Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)) +1 more, Unknown on 2024-10-08. Applicant: Omron Healthcare, Inc.. Device class: 2.

Clearance details

Device name as filed: 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.
Product code: Code QXY
Device class: Class 2
Regulation: 21 CFR 870.1135
Advisory panel: Cardiovascular
Date received: 2023-11-13
Decision date: 2024-10-08
Decision: Unknown
Clearance type: Direct
Location: Hoffman Estates, IL, US

View on FDA.gov ↗

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