510(k) Report

Devices descending from K020399

5 later devices reach Resperate; Model RR-150 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233580A Breathing System (ABS)Deepwell Dtx, Inc.20240—
+1K131586Canary Breathing SystemPalo Alto Health Sciences, Inc.20132—
+1K070467Health MaskPolar Wrap, LLC20070—
+2K180173FreespiraPalo Alto Health Sciences, Inc.20181—
+3K222101PrismGraymatters Health, Ltd.20230—