510(k) Report

Devices descending from K021485

11 later devices reach Biosomnia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101830Zmachine, Model DT-100Consolidated Research of Richmond, Inc.201110—
+2K242447Falcon HSTCompumedics Limited20250—
+2K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+2K142834DiscoverEEG System, Model DE-401Neurowave Systems, Inc.20155—
+2K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+3K213299Wireless EEG SystemPascall Systems, Inc.20222—
+3K192549Byteflies KitByteflies NV20201—
+3K192624ApneaTrakCadwell Industries, Inc.20200—
+4K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+4K251550NX01 (NX01)Naox Technologies Sas20250—
+4K240593VEEGix EEG SystemNeuroServo, Inc.20240—