ClearanceBrief
510(k) K031643 ยท BZG Spirometer, Diagnostic

SPIROTEL, MODEL 29-1020

ApplicantSdi Diagnostics, Inc., Easton MA, US
DecisionSubstantially Equivalent, Dec 9, 2003
ReceivedMay 27, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K031643

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.