510(k) K082785 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
| Applicant | Nihon Kohden America, Inc., Foothill CA, US |
| Decision | Substantially Equivalent, Nov 26, 2008 |
| Received | Sep 23, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082785
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.