MLO — Electrocardiograph, Ambulatory, With Analysis Algorithm Class II

FDA Device Classification

Classification Details

Product Code
MLO
Device Class
Class II
Regulation Number
870.2800
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241890philips medizin systeme böblingenPhilips Holter Analysis SystemMarch 21, 2025
K240794fourth frontier technologies pvtFrontier X PlusNovember 8, 2024
K200833vivaquantRX-1 Rhythm Express Remote Cardiac Monitoring SystemSeptember 2, 2020
K193177cardiocalmCER-SAugust 26, 2020
K182030bittium biosignalsFaros MobileNovember 8, 2018
K140847labtech kftCARDIOSPY ECG HOLTER SYSTEMSDecember 5, 2014
K131897vales and hills biomedical tech.CV3000 HOLTER ANALYSIS SYSTEMNovember 26, 2013
K130660inovise medicalAUDICOR CPAM WITH SDB (SINGLE SENSOR)October 11, 2013
K120462inovise medicalAUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED September 20, 2012
K111487norav medicalNH-301 AMBULATORY ECG ANALYSIS SOFTWARENovember 10, 2011
K110569inovise medicalAUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)October 24, 2011
K101273contec medical system coDYNAMIC ECG SYSTEM MODEL TLC5000September 30, 2011
K092853galix biomedical instrumentation3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SMJuly 9, 2010
K063339medick healthcareMEDICK MHM200 PERSONAL HEART MONITORJune 29, 2007
K062088diagnostic monitoring softwarePREMIER 11 HOLTERAugust 25, 2006
K051730global instrumentationMATRIX HOLTER SYSTEM, MODEL M12September 26, 2005
K042782ge medical systems information technologiesSEER MCSeptember 2, 2005
K043454medicompCARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410March 24, 2005
K042108novacorVISTA PLUSJanuary 19, 2005
K040753novacorR-TEST EVOLUTION 3June 10, 2004