ClearanceBrief
510(k) K254104 ยท BZD Ventilator, Non-Continuous (Respirator)

ResScan Essentials

ApplicantResmed Corp, San Diego CA, US
DecisionSubstantially Equivalent, May 27, 2026
ReceivedDec 19, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K254104

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.