Atlas FDA

MLO

32 FDA 510(k) clearances · Product code

186 daysmedian time to decision
296 days90th percentile
32clearances measured

FDA profile

Official device name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2800
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2009: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Philips Holter Analysis System (K241890)Philips Medizin Systeme Böblingen GmbH2025-03-21
Frontier X Plus (K240794)Fourth Frontier Technologies Pvt, Ltd.2024-11-08
RX-1 Rhythm Express Remote Cardiac Monitoring System (K200833)VivaQuant, Inc.2020-09-02
CER-S (K193177)Cardiocalm2020-08-26
Faros Mobile (K182030)Bittium Biosignals , Ltd.2018-11-08
CARDIOSPY ECG HOLTER SYSTEMS (K140847)Labtech Kft.2014-12-05
CV3000 HOLTER ANALYSIS SYSTEM (K131897)Vales & Hills Biomedical Tech. , Ltd.2013-11-26
AUDICOR CPAM WITH SDB (SINGLE SENSOR) (K130660)Inovise Medical, Inc.2013-10-11
AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) (K120462)Inovise Medical, Inc.2012-09-20
NH-301 AMBULATORY ECG ANALYSIS SOFTWARE (K111487)Norav Medical Corp.2011-11-10
AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) (K110569)Inovise Medical, Inc.2011-10-24
DYNAMIC ECG SYSTEM MODEL TLC5000 (K101273)Contec Medical System Co., Ltd.2011-09-30
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM (K092853)Galix Biomedical Instrumentation, Inc.2010-07-09
MEDICK MHM200 PERSONAL HEART MONITOR (K063339)Medick Healthcare , Ltd.2007-06-29
PREMIER 11 HOLTER (K062088)Diagnostic Monitoring Software2006-08-25
MATRIX HOLTER SYSTEM, MODEL M12 (K051730)Global Instrumentation, LLC2005-09-26
SEER MC (K042782)Ge Medical Systems Information Technologies2005-09-02
CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 (K043454)Medicomp, Inc.2005-03-24
VISTA PLUS (K042108)Novacor2005-01-19
R-TEST EVOLUTION 3 (K040753)Novacor2004-06-10
CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 (K024323)Biomedical Systems Corp.2003-06-30
IQMARK DIGITAL HOLTER (K031466)Brentwood Medical Technology Corp.2003-06-11
NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 (K012712)Norav Medical , Ltd.2002-05-08
C. NET 2100 (K010396)Cardionetics, Ltd.2001-10-04
2010 PLUS HOLTER FOR WINDOWS (K010949)Agilent Technologies2001-09-28
H-SCRIBE (K004017)Mortara Instrument, Inc.2001-06-11
GALIX GBI -3S-LP (K992706)Galix Biomedical Instrumentation, Inc.2001-03-15
2010 PLUS HOLTER FOR WINDOWS (K003940)Agilent Technologies2001-02-08
2010 PLUS HOLTER FOR WINDOWS (K003763)Agilent Technologies2001-01-05
R.TEST EVOLUTION (K993788)Novacor Div.2000-08-04
MODIFICATION TO ZYMED HOLTER 2000 (K992197)Zymed Medical Instrumentation1999-07-28
HOLTER 2000 (K990170)Zymed Medical Instrumentation1999-04-13

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Every clearance here is in the API, with alerts when new ones post.