510(k) K023456 ยท KPJ Chamber, Oxygen, Topical, Extremity
OXYBOX SYSTEM
| Applicant | Oxyfast Corporation, Cleveland OH, US |
| Decision | Substantially Equivalent, Feb 24, 2003 |
| Received | Oct 15, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023456
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2012 | Ogenix Corporation EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 4 Terminated |
KPJ | None listed |
| Sep 28, 2006 | Ogenix Corporation Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) Terminated |
KPJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.