510(k) K113821 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
| Applicant | Transonic Systems, Inc., Ithaca NY, US |
| Decision | Substantially Equivalent, Sep 7, 2012 |
| Received | Dec 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113821
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.