ClearanceBrief
510(k) K070321 ยท BZD Ventilator, Non-Continuous (Respirator)

TWILIGHT FULL FACE MASK

ApplicantInvacare Corp., Elyria OH, US
DecisionSubstantially Equivalent, Apr 30, 2007
ReceivedFeb 2, 2007
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K070321

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.