510(k) K133222 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
SAAD PATIENT MONITOR (SPM)
| Applicant | Hanin Medical Services Co., Ltd., Monroe CT, US |
| Decision | Substantially Equivalent, Aug 6, 2014 |
| Received | Oct 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133222
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.