510(k) K902628 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT
| Applicant | Biometric Research Institute, Inc., Arlington VA, US |
| Decision | Substantially Equivalent, Feb 25, 1991 |
| Received | Jun 13, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902628
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2006 | Edwards Lifesciences Llc EDWARDS VIGILANCE MONITORS
(FORMERLY BAXTER VIGILANCE MONITORS)
with software release 5.3 or earlier only. Patient monitor which measures cardiac output.
Models: VG, VGS, VGS1, VGS2, VG2, & IVM. Terminated |
DYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.