FDA 510(k) Applications for Medical Device Product Code "DTC"
(Analyzer, Pacemaker Generator Function)

FDA 510(k) Number Applicant Device Name Decision Date
K770865 ADCOR ELECTRONICS, INC. MONITOR, PACEMAKER 06/14/1977
K903966 BIO-TEK INSTRUMENTS, INC. EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 06/19/1991
K901332 BIOTRONIK, GMBH & CO. PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE 05/09/1990
K083674 BIOTRONIK, INC. PK-141 PATIENT CABLE 04/01/2009
K170815 Boston Scientific Corporation PSA Cable 07/06/2017
K844969 CORDIS CORP. CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) 05/01/1985
K760013 CORDIS CORP. PACER SYSTEMS ANALYZER (CORDIS) 07/20/1976
K800286 DART MEDICAL EQUIPMENT CRITERION II PACING SYSTEM MONITORS 03/12/1980
K792074 DEL MAR AVIONICS MODEL 674 PACER ANALYZER 12/27/1979
K011729 DNI NEVADA, INC. SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 08/30/2001
K781144 EDWARDS PACEMAKER SYSTEMS ANALYZER, PACER SYSTEM, PSA-5 08/23/1978
K791975 ELA MEDICAL, INC. PACING SYSTEM ANALYZER PSA SCE-22 01/31/1980
K792602 ELA MEDICAL, INC. SUSI II PACEMAKER SURVEILLANCE MONITOR 03/25/1980
K771922 INSTROMEDIX, INC. MINICLINIC TM 11/02/1977
K781349 INSTROMEDIX, INC. PACER-TRACER PULSE WIDTH 08/31/1978
K791762 INSTROMEDIX, INC. SELF CHECK 09/21/1979
K850077 MEDTRONIC VASCULAR MEDTRONIC 5311 PACING SYSTEM ANALYZER 07/16/1985
K812262 MEDTRONIC VASCULAR MEDTRONIC A-V PACING SYSTEM ANALYZER 06/17/1982
K884331 MEDTRONIC VASCULAR MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER 01/10/1989
K896632 MEDTRONIC VASCULAR MEDTRONIC MODEL 5401B TEST CABLE 12/13/1989
K910595 MEDTRONIC VASCULAR MODEL 5311B A-V PACING SYSTEM ANALYZER 05/07/1991
K961582 NORTH AMERICAN TECHNICAL SERVICES CORP. EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 11/08/1996
K882327 OSCOR MEDICAL CORP. PACER SENSING ANALYZER (PSA 100) 10/06/1988
K002497 PACE MEDICAL MODEL 4810 ANALYZER OUTPUT ADAPTER 10/10/2000
K910223 SEAMED CORP. CPI MODEL 2215/SEAMED MODEL 3400 03/19/1991
K851900 SEAMED CORP. SEA MED DDD PACING SYSTEM ANALYZER 07/19/1985
K860462 SEAMED CORP. SEAMED MODEL 3000 08/19/1986
K831697 SEAMED CORP. TELECTRONICS MODEL 2401 09/04/1984
K810604 TELECTRONICS, INC. ELECTRODE/PACER SYSTEM ANALYZER PMA 400 04/14/1981
K780717 VITATRON MEDICAL BV EXTERNAL TEST PULSE GENERATOR 06/30/1978


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