510(k) Report

Devices descending from K000405

6 later devices reach Intercure LTD. Respi-Low through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020399Resperate; Model RR-150Intercure, Ltd.20025—
+2K233580A Breathing System (ABS)Deepwell Dtx, Inc.20240—
+2K131586Canary Breathing SystemPalo Alto Health Sciences, Inc.20132—
+2K070467Health MaskPolar Wrap, LLC20070—
+3K180173FreespiraPalo Alto Health Sciences, Inc.20181—
+4K222101PrismGraymatters Health, Ltd.20230—