510(k) Report

Devices descending from K000396

18 later devices reach Apnoescreen Pro, Alpha Screen Pro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021138Sleepscreen/Apnoescreen CardioErich Jaeger GmbH200317—
+2K060708SomnoscreenSomnomedics GmbH & Co. KG200711—
+2K051907InnocorInnovision A/S20064—
+3K190561NICU V'02Cosmed Nordic Aps20200—
+3K201054SOMNOscreen plusSomnomedics GmbH20204—
+3K140861Somnotouch RespSomnomedics GmbH20150—
+3K102047Lci Option for InnocorInnovision A/S201101
+3K111314Morpheus OXWidemed, Ltd.20110—
+3K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+3K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+3K081485SomnowatchSomnomedics GmbH20080—
+3K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S20073—
+3K071556Somnoscreen EEG10-20Somnomedics GmbH20075—
+4K241288Noxturnal WebNox Medical Ehf20242—
+4K240700HomeSleepTest (HST, HST REM+)Somnomedics GmbH20240—
+4K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+5K261747Report StudioBeacon Biosignals, Inc.20260—
+5K260585Noxturnal WebNox Medical Ehf20260—