510(k) K113054 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
EQUIVITAL
| Applicant | Hidalgo Limited, Cambridge, GB |
| Decision | Substantially Equivalent, Feb 17, 2012 |
| Received | Oct 13, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113054
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.