510(k) K032755 ยท DQA Oximeter
MODEL 509M PULSE OXIMETER, MODEL 509M
| Applicant | Respironics Novametrix, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, May 21, 2004 |
| Received | Sep 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032755
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Respironics Novametrix, Inc. Model 509M Pulse Oximetry Interface Module
Software versions 2.0 or 2.5 Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.