510(k) Report

Devices descending from K011668

8 later devices reach Validation of the Breathid System, for the Detection of Helicbactor Pylori through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130524Breathid HP SystemExalenz Bioscience, Ltd.20137—
+2K173772BreathID Hp SystemExalenz Bioscience, Ltd.20181—
+2K162150BreathID Hp Lab SystemExalenz Bioscience, Ltd.20164—
+3K221896BreathID Hp SystemMeridian Bioscience Israel, Ltd.20220—
+3K173777BreathID Hp Lab SystemExalenz Bioscience, Ltd.20183—
+4K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel, Ltd.20221—
+4K193610BreathID Smart SystemExalenz Bioscience, Ltd.20202—
+5K223185BreathID® Smart SystemMeridian Bioscience Israel, Ltd.20220—