510(k) K122121 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
| Applicant | Pulsion Medical Systems SE, Westbrook CT, US |
| Decision | Substantially Equivalent, Aug 2, 2012 |
| Received | Jul 17, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122121
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.