510(k) K081267 ยท CAW Generator, Oxygen, Portable
HYGEIA-5 OXYGEN CONCENTRATOR
| Applicant | Kedl Internation Limited, Fort Myers FL, US |
| Decision | Substantially Equivalent, Sep 23, 2008 |
| Received | May 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081267
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.