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 |