ClearanceBrief
510(k) K192595 ยท BZK Spirometer, Monitoring (W/Wo Alarm)

ExSpiron 2Xi

ApplicantRespiratory Motion, Watertown MA, US
DecisionSubstantially Equivalent, Dec 17, 2019
ReceivedSep 20, 2019
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K192595

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.