FDA 510(k) Applications for Medical Device Product Code: QYX ()

FDA 510(k) Applications for Medical Device Product Code "QYX"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K103706	APPLIED CARDIAC SYSTEMS, INC.	THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR	08/24/2011
K982803	CARDIAC TELECOM CORP.	HEARTLINK, MODEL II	11/13/1998
K093288	CARDIONET, INC	CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION	04/08/2010
K052240	CARDIONET, INC	CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002	10/19/2005
K063222	CARDIONET, INC	CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004	11/14/2006
K072558	CARDIONET, INC	CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005	12/05/2007
K162956	CONTEX INTERNATIONAL TECHNOLOGIES (CANADA), INC.	NOWCARDIO SYSTEM	09/22/2017
K090696	CORVENTIS, INC.	NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM	06/19/2009
K133701	CORVENTIS, INC.	NUVANT MCT SYSTEM	02/06/2014
K113372	CORVENTIS, INC.	NUVANT, MOBILC CARDIAC TELEMETRY	03/07/2012
K111917	CORVENTIS, INC.	NUVANT, MOBILE CARDIAC TELEMETRY	08/24/2011
K133753	INFOBIONIC, INC.	MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR	09/19/2014
K160064	INFOBIONIC, INC.	MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System	03/11/2016
K163512	IRHYTHM TECHNOLOGIES, INC.	Zio AT ECG Monitoring System	06/02/2017
K240029	iRhythm Technologies, Inc.	Zio AT« device (A100A1001)	10/21/2024
K170565	LifeWatch Services, Inc	LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L	08/01/2017
K020632	MENNEN MEDICAL LTD.	ENGUARD REMOTE PATIENT MONITOR	03/15/2002
K233584	RhythMedix LLC	RhythmStar System	07/08/2024
K240653	SmartCardia SA	SmartCardia 7L Platform (MCT)	10/31/2024