ClearanceBrief
510(k) K223922 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph

SOMNUM (V.1.1.2.)

ApplicantHoneynaps Co., Ltd., Seoul, KR
DecisionSubstantially Equivalent, Aug 16, 2023
ReceivedDec 30, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K223922

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.