510(k) K100394 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A
| Applicant | Shanghai 3f Electronics Co, Ltd., Echo OR, US |
| Decision | Substantially Equivalent, Apr 15, 2010 |
| Received | Feb 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100394
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.