510(k) K861505 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER
| Applicant | American Medical Equipment, Inc., New York NY, US |
| Decision | Substantially Equivalent, Apr 10, 1987 |
| Received | Apr 23, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861505
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.