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510(k) DEN230076

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. — Product Code QXY

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
October 8, 2024
Date Received
November 13, 2023
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature
Device Class
Class II
Regulation Number
870.1135
Review Panel
CV
Submission Type

An oscillometric-based, over-the-counter, atrial fibrillation notification feature is a software algorithm for analysis of signals from an oscillometric, non-invasive blood pressure measurement system to screen for possible atrial fibrillation in the device user.

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