510(k) K946115 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
EK-VIEW(TM) ECG MANAGEMENT SYSTEM
| Applicant | Apcot Medical Systems, Philadelphia PA, US |
| Decision | Substantially Equivalent, Mar 1, 1995 |
| Received | Dec 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946115
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.