510(k) K981378 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
| Applicant | Datex-Engstrom, Inc., Tewksburt MA, US |
| Decision | Substantially Equivalent, Nov 3, 1998 |
| Received | Apr 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981378
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.