ClearanceBrief
510(k) K081855 ยท DJZ Devices, Breath Trapping, Alcohol

IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)

ApplicantCanada, Inc., Atlanta GA, US
DecisionSubstantially Equivalent, Dec 19, 2008
ReceivedJun 30, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K081855

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.