510(k) Report

Devices descending from K120465

9 later devices reach Earlysense (Everon) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+1K131379EarlysenseEarlysense, Ltd.20137—
+2K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+2K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+2K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+3K253274BedDot (G1)Intelligent Dots, LLC20260—
+3K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+4K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+5K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—