510(k) K951485 ยท JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
AVOXIMETER 4000
| Applicant | A-Vox Systems, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Nov 6, 1995 |
| Received | Mar 30, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951485
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2011 | International Technidyne Corp. AVOXimeter 1000, AVOXimeter 4000
1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced soft Terminated |
DQA | None listed |
| Aug 6, 2008 | International Technidyne Corp. International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220 Terminated |
JKS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.