510(k) K772127 ยท BYF Mask, Oxygen, Low Concentration, Venturi
OXYGEN MASK, AIR-ENTRAINMENT
| Applicant | Salter Labs, Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 3, 1978 |
| Received | Nov 11, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K772127
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 26, 2011 | Salter Laboratories, Division of Regulatory Affairs Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs;
Salter Labs, Arvin, CA 93203
Intended usage: respiratory therapy. Terminated |
BYF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.