510(k) Report

Devices descending from K002135

13 later devices reach Sleepstrip Disposable Apnea Screener through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112822Sleepstrip IIS.L.P., Ltd.20116—
+1K030869BitestripS.L.P., Ltd.20043—
+1K022294ApneacheckIm Systems20031—
+2K200654Rubicon SA SystemDymedix Diagnostics, Inc.20200—
+2K173974DrowzleResonea, Inc.20195—
+2K113677Grindcare MeasureMedotech A/S20120—
+2K092675GrindcareMedotech A/S20102—
+3K231667Withings Sleep RxWithings20240—
+3K213360SleepCheckRxResapp Health20220—
+3K210480AcuPebble SAAcurable Limited20212—
+3K163448GrindCare SystemSunstar Suisse S.A.20170—
+4K222950AcuPebble OX100Acurable Limited20231—
+5K243092AcuPebble Ox (200)Acurable Limited20250—