510(k) Report

Devices descending from K173777

3 later devices reach BreathID Hp Lab System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel, Ltd.20221—
+1K193610BreathID Smart SystemExalenz Bioscience, Ltd.20202—
+2K223185BreathID® Smart SystemMeridian Bioscience Israel, Ltd.20220—