JOQ — Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) Class II

FDA Device Classification

Classification Details

Product Code
JOQ
Device Class
Class II
Regulation Number
870.1750
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K173439fischer medicalBloom2 Programmable Electrophysiology StimulatorMarch 29, 2018
K092913ep medsystemsEP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04October 16, 2009
K072200micropace ptySTIMLABOctober 26, 2007
K070743st cardio technologiesZ6 STIMULATORJuly 2, 2007
K041442ep medsystemsEP-4 CLINICAL STIMUTATORSeptember 14, 2004
K040207ep medsystemsEP-4 CLINICAL STIMULATORFebruary 27, 2004
K011826micropace ptyEPS320 CARDIAC STIMULATORJanuary 24, 2002
K991293fischer medical technologiesEPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOMay 5, 2000
K963579radionicsPACE-1A CARDIAC STIMULATORNovember 8, 1996
K935590ep medicalEP MEDICAL, INC. EP-3 CLINICAL STIMULATORMay 5, 1994
K900553ep technologiesCONSTANT CURRENT STIMULATOR MODEL 022101March 13, 1990
K893094heartware intlHB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEMOctober 2, 1989
K861368medtronic vascularMEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATORAugust 4, 1986
K852746seamedEXTERNAL PACEMAKER TELECTRONICS TE200September 12, 1985
K844815cordisCORDIS ELECTROPHYSIOLOGY STIMULATORJune 11, 1985
K851091medtronic vascularMEDTRONIC MODEL 5328 PROGRAM-STIMULATORApril 16, 1985
K843718medtronic vascularPROGRAMMABLE STIMULATOR 5326September 27, 1984
K833421medtronic vascularPROGRAMMABLE STIMULATOR 2352January 30, 1984