ClearanceBrief
510(k) K043528 ยท BZG Spirometer, Diagnostic

SPIROTEL

ApplicantMir Medical Intl. Research Srl, Roma, IT
DecisionSubstantially Equivalent, Jul 19, 2005
ReceivedDec 21, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K043528

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.