510(k) Report

Devices descending from K021138

17 later devices reach Sleepscreen/Apnoescreen Cardio through their predicates, nearest generation first.

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