510(k) K922394 ยท LOS
CARDIOFAX Q ECG-8420A
| Applicant | Nihon Kohden America, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 1, 1994 |
| Received | May 20, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922394
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.