ClearanceBrief
510(k) K121379 ยท CBK Ventilator, Continuous, Facility Use

PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY

ApplicantAiron Corporation, Melbourne FL, US
DecisionSubstantially Equivalent, Oct 11, 2012
ReceivedMay 8, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K121379

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.