510(k) Report

Devices descending from K092062

10 later devices reach Everon 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+2K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+2K131379EarlysenseEarlysense, Ltd.20137—
+3K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+3K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+3K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+4K253274BedDot (G1)Intelligent Dots, LLC20260—
+4K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+5K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+6K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—