510(k) Report

Devices descending from K082315

4 later devices reach EC50 Micro+ Smokerlyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173238ToxCOBedfont Scientific, Ltd.20190—
+1K171408Carbon Monoxide Breath Sensor System (COBSS)Carrot Sense, Inc.20172—
+2K211918iCOquit® Smokerlyzer®Bedfont Scientific, Ltd.20210—
+2K201206Pivot Breath SensorCarrot, Inc.20210—