510(k) K852618 ยท BYF Mask, Oxygen, Low Concentration, Venturi
OXY-DIAL
| Applicant | Ashai Co. , Ltd., Australia, AU |
| Decision | Substantially Equivalent, Sep 18, 1985 |
| Received | Jun 20, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852618
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.