510(k) K050858 ยท DPS Electrocardiograph
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM
| Applicant | Heartlab, Inc., Westerly RI, US |
| Decision | Substantially Equivalent, Jun 29, 2005 |
| Received | Apr 5, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K050858
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2009 | AGFA Corp. AGFA IMPAX HeartStation ECG Management System. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.