510(k) K151027 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
zensor system
| Applicant | Intelesens Limited, Belfast, GB |
| Decision | Substantially Equivalent, Oct 2, 2015 |
| Received | Apr 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151027
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.