510(k) K011670 ยท DQA Oximeter
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
| Applicant | Datex-Ohmeda, Tewksbury MA, US |
| Decision | Substantially Equivalent, Jun 26, 2001 |
| Received | May 30, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011670
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2003 | Datex-Ohmeda Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT) Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.