510(k) K020324 ยท CAW Generator, Oxygen, Portable
LIFESTYLE OXYGEN CONCENTRATOR
| Applicant | Airsep Corp., Buffalo NY, US |
| Decision | Substantially Equivalent, Mar 13, 2002 |
| Received | Jan 31, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020324
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2024 | Caire, Inc. CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. Completed |
CAW | None listed |
| Nov 15, 2024 | Caire, Inc. CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. Completed |
CAW | None listed |
| Feb 2, 2013 | Oxus America, Inc. Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400.
Also branded as Reliability Plus byDrive.
The Portable Oxygen Concentrator is intended to deliver concentrated oxygen fo Terminated |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.