510(k) K901034 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
| Applicant | Nihon Kohden America, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 19, 1990 |
| Received | Mar 6, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901034
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.