Omron Healthcare, Inc. · Class II · Cleared Oct 8, 2024
| K-number | DEN230076 |
| Device name | 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 | QXY |
| Device class | Class II |
| Decision date | Oct 8, 2024 |
| Decision | Not Substantially Equivalent |
| Regulation | — |
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