510(k) Report

Devices descending from K130524

7 later devices reach Breathid HP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173772BreathID Hp SystemExalenz Bioscience, Ltd.20181—
+1K162150BreathID Hp Lab SystemExalenz Bioscience, Ltd.20164—
+2K221896BreathID Hp SystemMeridian Bioscience Israel, Ltd.20220—
+2K173777BreathID Hp Lab SystemExalenz Bioscience, Ltd.20183—
+3K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel, Ltd.20221—
+3K193610BreathID Smart SystemExalenz Bioscience, Ltd.20202—
+4K223185BreathID® Smart SystemMeridian Bioscience Israel, Ltd.20220—