510(k) K220526 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
HD+12, HD+15
| Applicant | Cardioline S.P.A, Trento, IT |
| Decision | Substantially Equivalent, May 15, 2023 |
| Received | Feb 24, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220526
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2026 | Midmark Corporation Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080
Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18. Open, Classified |
DRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.