ClearanceBrief
510(k) K210844 ยท BZD Ventilator, Non-Continuous (Respirator)

DreamWear Silicone Pillows Mask

ApplicantRespironics, Inc., Murrysville PA, US
DecisionSubstantially Equivalent, Aug 24, 2021
ReceivedMar 22, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K210844

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.