510(k) Report

Devices descending from K001013

49 later devices reach Monet Acquisition System for Eeg and Polysomnography through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031202Medipalm-20Braebon Medical Corp.200348—
+2K073682Embletta GoldEmbla Systems, Inc.2008411
+2K071782Micromed Brain Spy Plus, Embia Titanium DevicesMicromed S.P.A.20084—
+2K061764Medibyte, Model MP8Braebon Medical Corp.20060—
+3K171384Micromed BRAIN QUICK systemMicromed S.P.A.201801
+3K122196Cervello Bio-Potential Signal Acquistion System Product FamilyBlackrock Neuromed, LLC20133—
+3K122516Embletta MPREmbla Systems2013271
+3K092003CPC Sleep Data Recorder, Model M1, and Application SoftwareMyCardio, LLC20094—
+3K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+4K210593Onera Sleep Test System (Onera STS)Onera B.V.20223—
+4K203343Wesper LabWesper, Inc.20211—
+4K163696SleepImage SystemMycardio, LLC Dba Sleepimage.20173—
+4K161579Watch-PAT200UItamar Medical, Ltd.201720—
+4K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+4K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd.20151—
+4K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+4K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+5K260050WRAP SystemHuneo, LLC20260—
+5K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+5K223573Onera Sleep Test System (Onera STS)Onera B.V.20231—
+5K221816Wesper LabWesper, Inc.20230—
+5K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd.20220—
+5K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+5K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+5K191031NightOwlEctosense NV20205—
+5K182618SleepImage SystemMycardio, LLC Dba Sleepimage.20192—
+5K180775Watch-PAT300Itamar Medical, Ltd.201812—
+6K252628CassieWesper, Inc.20260—
+6K243220Onera STS 2 (ONERA STS 2)Onera B.V.20250—
+6K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+6K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+6K231355AuroraEnsodata20240—
+6K231546SomfitCompumedics Limited20231—
+6K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+6K213463NightOwlEctosense NV20213—
+6K183559WatchPAT ONEItamar Medical, Ltd.20195—
+7K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+7K252383Somfit DCompumedics Limited20250—
+7K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+7K220095ANNE SleepSibel, Inc.20224—
+7K220028NightOwlEctosense NV20222—
+8K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+8K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+8K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+8K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+9K254042WatchPAT SWItamar Medical, Ltd.20260—
+9K244027Sansa HsatHuxley Medical20252—
+10K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+10K252497Sansa HsatHuxley Medical20250—