510(k) DEN230076
DEN230076 is an FDA 510(k) premarket notification submitted by Omron Healthcare, Inc. for the 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))". The FDA issued a decision of De Novo Granted on October 8, 2024. The device falls under product code QXY (Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature), a Class II device regulated under 21 CFR 870.1135. Omron Healthcare, Inc. has at least 10 other 510(k) clearances on record.
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.