510(k) K233326 ยท DQK Computer, Diagnostic, Programmable
Merge Hemo, Model RCSV2
| Applicant | Merge Healthcare Incorporated, Hartland WI, US |
| Decision | Substantially Equivalent, Jun 21, 2024 |
| Received | Sep 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233326
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2025 | Merge Healthcare, Inc. Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1
Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that mo Open, Classified |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.