ClearanceBrief
510(k) K801461 ยท FMZ Incubator, Neonatal

THERMA-SHIELD

ApplicantOlympic Medical Corp., Walker MI, US
DecisionSubstantially Equivalent, Jul 28, 1980
ReceivedJun 24, 1980
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K801461

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.