510(k) K922075 ยท DQA Oximeter
AVOXIMETER
| Applicant | A-Vox Systems, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Nov 4, 1992 |
| Received | May 4, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922075
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2024 | Accriva Diagnostics, Inc. AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter. Completed |
DQA | None listed |
| Aug 6, 2008 | International Technidyne Corp. International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220 Terminated |
DQA | None listed |
| Aug 6, 2008 | International Technidyne Corp. International Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers: AVOX1000E-110 and AVOX1000E-220 Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.