ClearanceBrief
510(k) K080256 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure

PULMODYNE CHF FLOW GENERATOR SYSTEM

ApplicantPulmodyne, Bonita Springs FL, US
DecisionSubstantially Equivalent, May 9, 2008
ReceivedJan 31, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K080256

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.