ClearanceBrief
510(k) K091853 ยท BZK Spirometer, Monitoring (W/Wo Alarm)

WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014

ApplicantNspire Health, Inc., Longmont CO, US
DecisionSubstantially Equivalent, Sep 21, 2009
ReceivedJun 23, 2009
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K091853

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.