510(k) K112448 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
PULSIOFLEX
| Applicant | Pulsion Medical Systems, Inc., Westbrook CT, US |
| Decision | Substantially Equivalent, Sep 22, 2011 |
| Received | Aug 25, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112448
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.