510(k) K944257 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
LIONHEART 3 MULTI-PARAMETER SIMULATOR
| Applicant | Bio-Tek Instruments, Inc., Winooski VT, US |
| Decision | Substantially Equivalent, Sep 21, 1994 |
| Received | Aug 31, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944257
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.