510(k) K123048 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO
| Applicant | Advanced Instrumentations, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Jan 11, 2013 |
| Received | Sep 28, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123048
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.