510(k) K862463 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
| Applicant | Nihon Kohden America, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 5, 1986 |
| Received | Jun 30, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862463
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.