510(k) K052883 ยท DQK Computer, Diagnostic, Programmable
CARDIOSERVER
| Applicant | Datrix, Escondido CA, US |
| Decision | Substantially Equivalent, Nov 1, 2005 |
| Received | Oct 13, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052883
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2023 | Baxter Healthcare Corporation Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x. Open, Classified |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.