510(k) K973918 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
| Applicant | Nihon Kohden America, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jan 13, 1998 |
| Received | Oct 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973918
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.