DRX — Electrode, Electrocardiograph Class II

FDA Device Classification

Classification Details

Product Code
DRX
Device Class
Class II
Regulation Number
870.2360
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K171244nimbleheartPhysiotraceAugust 23, 2017
K140096hmicroHMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGEJuly 24, 2014
K123658zephyr technology corporationBIOMODULE 3-M1April 24, 2013
K101576team innovationsCENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESJuly 22, 2010
K101685integral processIP-SETJuly 1, 2010
K100129ambuAMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XJune 11, 2010
K093327shanghai intco electrode manufacturing coINTCO TAB ELECTRODEMay 10, 2010
K100315i needmd12 LEAD GLOVEApril 23, 2010
K092744r and d medical productsNEONATAL ECG ELECTRODE, M203KENDecember 10, 2009
K092389suzuken coDISPOSAL ECG ELECTRODES, MODEL EASYRODEOctober 13, 2009
K090496cardiac lead technologiesQWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCHSeptember 1, 2009
K092291leonhard langSKINTACT AND VARIOUS OTHER TRADENAMESAugust 21, 2009
K091856conmed corporationCONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 271August 7, 2009
K090180vermedTENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODEJune 17, 2009
K083677commwellPHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1March 10, 2009
K083148bio protechTELECTRODE WET GEL ECG ELECTRODENovember 7, 2008
K080602inovise medicalAUDICOR SENSOR, MODELS: 2.0, 3.0September 25, 2008
K080106leonhard langSKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVEFebruary 1, 2008
K073104leonhard langSKINTACT AND VARIOUS OTHER TRADENAMESNovember 16, 2007
K071576textronicsTEXTRONICS ECG ELECTRODENovember 2, 2007