510(k) K153275 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Aingeal Activity System
| Applicant | Intelesens, Ltd., Belfast, GB |
| Decision | Substantially Equivalent, Feb 26, 2016 |
| Received | Nov 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153275
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.