ClearanceBrief
510(k) K230915 · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask

ApplicantVyaire Medical, Inc., Mettawa IL, US
DecisionSubstantially Equivalent, Nov 12, 2024
ReceivedMar 31, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K230915

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.