ClearanceBrief
510(k) K200565 ยท BZD Ventilator, Non-Continuous (Respirator)

Galapogos

ApplicantResmed Corp, San Diego CA, US
DecisionSubstantially Equivalent, Jan 17, 2021
ReceivedMar 4, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K200565

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.