510(k) K080116 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
| Applicant | Transonic Systems, Inc., Ithaca NY, US |
| Decision | Substantially Equivalent, Sep 8, 2008 |
| Received | Jan 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080116
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2013 | Transonic Systems Inc HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only.
Product Usage: is indicated for use in patients greater than or Terminated |
DXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.