510(k) Report

Devices descending from K082113

17 later devices reach Nox T3, Noxturnal (PC Application) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242290DormoTech NLabDormotech Medical, Ltd.20250—
+1K143272ApneaLink AirResmed Germany, Inc.20157—
+1K124062QDC-Pro, and Nox-RipNox Medical20133—
+1K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+2K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+2K163665MATRx plusZephyr Sleep Technologies20173—
+2K151361Nox RIP Belts & CablesNox Medical Ehf20152—
+2K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+2K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+3K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH20260—
+3K242447Falcon HSTCompumedics Limited20250—
+3K192624ApneaTrakCadwell Industries, Inc.20200—
+3K171304Maxxi Rip SensorNeurovirtual USA, Inc.20190—
+3K181996MATRx PlusZephyr Sleep Technologies20182—
+3K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—
+4K191925MATRx PlusZephyr Sleep Technologies20191—
+5K200695MATRx plusZephyr Sleep Technologies20200—