FDA 510(k) Applications for Medical Device Product Code "DTE"
(Pulse-Generator, Pacemaker, External)

FDA 510(k) Number Applicant Device Name Decision Date
K821791 AMERICAN PACEMAKER CORP. EXTERNAL PULSE GENERATOR - EV4542 07/06/1982
K853194 BIOTRONIK SALES, INC. ERA-20 03/11/1987
K964190 BIOTRONIK, INC. ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER 07/10/1997
K042708 BIOTRONIK, INC. ERA 3000 PACING SYSTEM ANALYZER 10/20/2004
K802221 CORDIS CORP. CHRONOCOR IV MODEL 250 11/19/1980
K792536 CYNERGY CYNERGY MODEL 182 01/31/1980
K801596 CYNERGY CYNERGY MODEL 184 09/16/1980
K792223 CYNERGY PACESETTER MODEL 350 11/30/1979
K810566 CYNERGY SIEMENS MODEL 146-146A EXTERNAL PULSE G 04/01/1981
K023080 GALIX BIOMEDICAL INSTRUMENTATION, INC. GALIX PACESTAR 06/11/2003
K801055 INTERMEDICS, INC. COMPUPACE, 524-01 PACER SYSTEM COMPUTER 10/31/1980
K781327 INTERMEDICS, INC. PULSE GENERATOR, MODEL 240, EXTERNAL 12/11/1978
K971474 MEDTRONIC VASCULAR MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL 07/14/1997
K782108 MEDTRONIC VASCULAR MEDTRONIC MODEL 546 12/29/1978
K893633 MEDTRONIC VASCULAR MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE 06/20/1989
K910237 MEDTRONIC VASCULAR MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR 02/25/1991
K803313 MEDTRONIC VASCULAR PACING SYSTEM ANALYZER 02/23/1981
K150246 Medtronic, Inc Medtronic Model 5392 External Pulse Generator (EPG) 02/18/2015
K132924 MEDTRONIC, INC. MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) 10/31/2013
K180873 Medtronic, Inc. Medtronic Model 53401 External Pulse Generator (EPG) 04/19/2018
K162550 Medtronic, Inc. Medtronic Model 5392 External Pulse Generator (EPG) 10/12/2016
K181973 Medtronic, Inc. Medtronic Model 5392 External Pulse Generator (EPG) 08/21/2018
K162054 MEDTRONIC, INC. Medtronic Temporary External Pacemaker 53401 10/18/2016
K831768 OSCOR INC. EXTERNAL PULSE GENERATOR FOR TEMP. STIM 12/16/1983
K923621 OSCOR MEDICAL CORP. EXTERNAL DEMAND PACEMAKER 05/19/1993
K022939 OSYPKA MEDICAL, INC. OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES 10/03/2002
K020896 OSYPKA MEDICAL, INC. OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE 06/14/2002
K033130 OSYPKA MEDICAL, INC. PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR 10/31/2003
K123916 OSYPKA MEDICAL, INC. PSA SERIES 04/09/2013
K011980 PACE MEDICAL ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 09/12/2001
K913805 PACE MEDICAL MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER 11/19/1991
K871915 PACE MEDICAL MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543 06/10/1987
K925143 PACE MEDICAL MODEL 4800 ACCUPACE PACING SYSTEM ANALYER 09/27/1994
K896352 PACE MEDICAL MODEL EC4542G MINIATURE 01/24/1990
K870323 PACE MEDICAL MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER 03/03/1987
K902679 PACE MEDICAL MODELS 4201, 4231 & 4235 EXTENSION CABLES 07/19/1990
K002204 PACE MEDICAL PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V 10/18/2000
K001180 PACE MEDICAL TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 06/27/2000
K970347 PALADIN MEDICAL, INC. MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM 08/29/1997
K940467 REMINGTON MEDICAL, INC. REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601 11/01/1994
K850822 SEAMED CORP. CHRONOCOR V EXTERNAL PACER, MODEL 297A 07/16/1985
K915364 SEAMED CORP. CHRONOCOR VI MODEL 5012 02/07/1992
K923398 SEAMED CORP. CPI MODEL 2215 08/14/1992
K912507 SEAMED CORP. CPI MODEL 2215 & SEAMED MODEL 3400 09/03/1991
K831381 SEAMED CORP. RAPID ATRIAL PACER 08/31/1983
K863903 SEAMED CORP. SEA MED MODEL 6000 12/10/1986
K823048 SEAMED CORP. SEA MED MODEL 880 12/15/1982
K843777 SEAMED CORP. SEAMED 4000 02/01/1985
K872551 SEAMED CORP. SEAMED MODEL 3200 07/31/1987
K883930 SEAMED CORP. SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY 11/09/1988
K854648 SEAMED CORP. SEAMED MODEL 4000 01/16/1986
K843807 SEAMED CORP. SEAMED MODEL 6000 02/01/1985
K820570 SEAMED CORP. SEAMED, #540 - SIEMENS, #146F TELECTRO 06/03/1982
K970497 SULZER OSCOR, INC. PACE 101H 06/04/1997
K900220 SYNCHROMED CORP. TRANS-PACE 100 07/17/1990
K801953 TELECTRONICS, INC. EXTERNAL, TEMP. PORTABLE CARDIAC GENER 10/23/1980
K800088 TELECTRONICS, INC. PACEMAKER ELECTRODE INSERTER AIDE 01/29/1980
K811092 TELECTRONICS, INC. STERILE PACKAGING 07/01/1981
K934016 ZOLL MEDICAL CORP. POWERCHARGER 10/18/1994
K960676 ZOLL MEDICAL CORP. ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004 06/05/1996


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