510(k) K113183 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
| Applicant | Shanghai 3f Electronics Co, Ltd., Echo OR, US |
| Decision | Substantially Equivalent, Feb 9, 2012 |
| Received | Oct 28, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K113183
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.