FDA 510(k) Applications for Medical Device Product Code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)

FDA 510(k) Applications for Medical Device Product Code "MLO"
(Electrocardiograph, Ambulatory, With Analysis Algorithm)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K003763	AGILENT TECHNOLOGIES	2010 PLUS HOLTER FOR WINDOWS	01/05/2001
K003940	AGILENT TECHNOLOGIES	2010 PLUS HOLTER FOR WINDOWS	02/08/2001
K010949	AGILENT TECHNOLOGIES	2010 PLUS HOLTER FOR WINDOWS	09/28/2001
K024323	BIOMEDICAL SYSTEMS CORP.	CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000	06/30/2003
K182030	Bittium Biosignals Ltd.	Faros Mobile	11/08/2018
K031466	BRENTWOOD MEDICAL TECHNOLOGY CORP.	IQMARK DIGITAL HOLTER	06/11/2003
K193177	CardioCalm	CER-S	08/26/2020
K010396	CARDIONETICS, LTD.	C. NET 2100	10/04/2001
K101273	CONTEC MEDICAL SYSTEM CO., LTD.	DYNAMIC ECG SYSTEM MODEL TLC5000	09/30/2011
K062088	DIAGNOSTIC MONITORING SOFTWARE	PREMIER 11 HOLTER	08/25/2006
K092853	GALIX BIOMEDICAL INSTRUMENTATION, INC.	3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM	07/09/2010
K992706	GALIX BIOMEDICAL INSTRUMENTATION, INC.	GALIX GBI -3S-LP	03/15/2001
K042782	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES	SEER MC	09/02/2005
K051730	GLOBAL INSTRUMENTATION, LLC	MATRIX HOLTER SYSTEM, MODEL M12	09/26/2005
K110569	INOVISE MEDICAL, INC.	AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)	10/24/2011
K120462	INOVISE MEDICAL, INC.	AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)	09/20/2012
K130660	INOVISE MEDICAL, INC.	AUDICOR CPAM WITH SDB (SINGLE SENSOR)	10/11/2013
K140847	LABTECH KFT.	CARDIOSPY ECG HOLTER SYSTEMS	12/05/2014
K063339	MEDICK HEALTHCARE LTD.	MEDICK MHM200 PERSONAL HEART MONITOR	06/29/2007
K043454	MEDICOMP, INC.	CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410	03/24/2005
K004017	MORTARA INSTRUMENT, INC.	H-SCRIBE	06/11/2001
K111487	NORAV MEDICAL CORP.	NH-301 AMBULATORY ECG ANALYSIS SOFTWARE	11/10/2011
K012712	NORAV MEDICAL LTD.	NORAV HOLTER SYSTEM, MODEL NH-300 V1.07	05/08/2002
K040753	NOVACOR	R-TEST EVOLUTION 3	06/10/2004
K042108	NOVACOR	VISTA PLUS	01/19/2005
K993788	NOVACOR DIV.	R.TEST EVOLUTION	08/04/2000
K131897	VALES & HILLS BIOMEDICAL TECH. LTD.	CV3000 HOLTER ANALYSIS SYSTEM	11/26/2013
K200833	VivaQuant Inc.	RX-1 Rhythm Express Remote Cardiac Monitoring System	09/02/2020
K990170	ZYMED MEDICAL INSTRUMENTATION	HOLTER 2000	04/13/1999
K992197	ZYMED MEDICAL INSTRUMENTATION	MODIFICATION TO ZYMED HOLTER 2000	07/28/1999

FDA 510(k) Applications for Medical Device Product Code "MLO" (Electrocardiograph, Ambulatory, With Analysis Algorithm)

FDA 510(k) Applications for Medical Device Product Code "MLO"
(Electrocardiograph, Ambulatory, With Analysis Algorithm)