ClearanceBrief
510(k) K111148 ยท BZD Ventilator, Non-Continuous (Respirator)

S8 ASPEN WITH H4I PLUS

ApplicantResmed Corp, San Diego CA, US
DecisionSubstantially Equivalent, Jun 30, 2011
ReceivedApr 22, 2011
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K111148

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.