510(k) Report

Devices descending from K042253

4 later devices reach Sleepsense Sleep Sensors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180001Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable…Embla Systems20190—
+1K173793XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems20191—
+1K080375RMX Physiological Data RecorderS.L.P., Ltd.20080—
+2K242424Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc.20240—