Panels › Cardiovascular › Product code QXY · Class 2
Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature
Regulation 870.1135
0510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QXY
| Company | 510(k)s | Recalls |
|---|---|---|
| Omron Healthcare, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 2024 | DEN230076 | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pre Omron Healthcare, Inc. | QXY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.