510(k) K103134 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
FUKUDA DENSHI
| Applicant | Fukuda Denshi USA, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Mar 11, 2011 |
| Received | Oct 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103134
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.