510(k) K082829 ยท OLF Medevac Use Oxygen Generator
AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)
| Applicant | Carleton Life Support Systems, Inc., Davenport IA, US |
| Decision | Substantially Equivalent, Dec 22, 2008 |
| Received | Sep 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082829
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2009 | Carleton Life Support Systems Inc Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular Sieve, S/A P/N: 70309-03900-101, Mfg P/N 3261165-0101. The firm name on the label is Carleton Terminated |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.