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DRO — Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) Class II

FDA Device Classification

Classification Details

Product Code
DRO
Device Class
Class II
Regulation Number
870.5550
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K012404katechoK-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85October 12, 2001
K012218ludlow companyLUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESOctober 12, 2001
K000660medical data electronicsESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELSMarch 28, 2000
K983196tz medicalPADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)September 15, 1999
K983232tz medicalPADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2September 15, 1999
K974034medical research laboratoriesPORTABLE INTENSIVE CARE UNITMarch 2, 1998
K962547marquette electronicsCARDIOSERV PMarch 6, 1997
K963120marquette electronicsRESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEMFebruary 28, 1997
K961138medical data electronicsESORT II + 400 SERIES MONITORDecember 10, 1996
K950856zoll medicalZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY December 29, 1995
K951593physio-controlLIFEPAK 11December 29, 1995
K950483hewlett-packardHEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITORMay 22, 1995
K926175katechoK-DEFIB/PACE CARBON ELECTRODEApril 15, 1993
K915757hewlett-packardMODELS M1722A, M1723A, M1724A DEFIBRILLATORSJuly 30, 1992
K915328katechoGEL-TACJune 29, 1992
K914955katechoK-DEFIB/PACE ELECTRODEMay 14, 1992
K912599physio-controlQUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELECSeptember 11, 1991
K911956zmiZOLL PD-1400 PACER/DEFIBRILLATORJuly 31, 1991
K910661cardiotronicsMODEL 205 SHOCK-TRODEMay 2, 1991
K903437keller medical specialties productsDISPOS ACCESS EXTERNAL CARDIAC PACEMAKERNovember 16, 1990