510(k) Report

Devices descending from K162150

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173777BreathID Hp Lab SystemExalenz Bioscience, Ltd.20183—
+2K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel, Ltd.20221—
+2K193610BreathID Smart SystemExalenz Bioscience, Ltd.20202—
+3K223185BreathID® Smart SystemMeridian Bioscience Israel, Ltd.20220—