510(k) K180472 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
ViSi Mobile Monitoring System
| Applicant | Sotera Wireless, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 19, 2018 |
| Received | Feb 22, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180472
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.