FDA 510(k) Applications for Medical Device Product Code: DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive))

FDA 510(k) Applications for Medical Device Product Code "DRO"
(Pacemaker, Cardiac, External Transcutaneous (Non-Invasive))

FDA 510(k) Number	Applicant	Device Name	Decision Date
K012404	KATECHO, INC.	K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85	10/12/2001
K962547	MARQUETTE ELECTRONICS, INC.	CARDIOSERV P	03/06/1997
K963120	MARQUETTE ELECTRONICS, INC.	RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM	02/28/1997
K000660	MEDICAL DATA ELECTRONICS	ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413	03/28/2000
K961138	MEDICAL DATA ELECTRONICS	ESORT II + 400 SERIES MONITOR	12/10/1996
K974034	MEDICAL RESEARCH LABORATORIES, INC.	PORTABLE INTENSIVE CARE UNIT	03/02/1998
K012218	THE LUDLOW COMPANY LP	LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES	10/12/2001
K983196	TZ MEDICAL, INC.	PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)	09/15/1999
K983232	TZ MEDICAL, INC.	PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT	09/15/1999