510(k) K944262 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
ECG MONITOR
| Applicant | Fukuda Denshi USA, Inc., Great Neck, NY, US |
| Decision | Substantially Equivalent, May 12, 1995 |
| Received | Aug 30, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944262
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.