510(k) K043520 ยท CAW Generator, Oxygen, Portable
EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR
| Applicant | Emg Technology Co., Ltd., Baltimore MD, US |
| Decision | Substantially Equivalent, Oct 21, 2005 |
| Received | Dec 20, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K043520
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2008 | Medline Industries Inc Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to pat Terminated |
CAW | None listed |
| Jul 23, 2008 | Medline Industries Inc Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS021; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to Terminated |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.