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MLD — Monitor, St Segment With Alarm Class II

FDA Device Classification

Classification Details

Product Code
MLD
Device Class
Class II
Regulation Number
870.1025
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K101602criticare systemsVITAL SIGNS MONITORSeptember 1, 2010
K080461philips medical systemsSTAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0March 13, 2008
K022740datex-ohmedaDATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARNovember 14, 2002
K012837datex-ohmedaMODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIESSeptember 14, 2001
K002105siemens medical solutions usaSIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSISDecember 5, 2000
K992323datex-ohmedaDATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIESNovember 1, 1999
K982104medical data electronicsESCORT-LINK CENTRAL STATION MONITOR MODEL 20500November 25, 1998
K974492siemens medical solutions usaSIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSFebruary 26, 1998
K972121protocol systemsACUITY CENTRAL STATIONNovember 7, 1997
K953175datex division instrumentariumAS/3 ESTPR MODULEFebruary 6, 1997
K960272marquette electronicsEAGLE 3000/3100 PATIENT MONITOROctober 2, 1996
K960934hewlett-packardHP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24June 14, 1996
K935020invivo researchOMNI-TRAC MODIFICATIONApril 26, 1995
K920429hewlett-packardMODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEMJuly 20, 1993