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510(k) K040207

Device
EP-4 CLINICAL STIMULATOR
Applicant
EP MEDSYSTEMS
510(k) number
K040207
Product code
JOQ  
Decision
Substantially Equivalent (SESE)
Decision date
2004-02-27
Date received
2004-01-30
Regulation
870.1750
Classification name
Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JAMES E KUHN
Address
Cooper Run Executive Park 575 Rt. 73 N., Bldg. D West Berlin NJ US 08091 08091

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JOQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K173439Bloom2 Programmable Electrophysiology StimulatorFischer Medical2018-03-29
K092913EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04Ep Medsystems2009-10-16
K072200STIMLABMicropace Pty, Ltd.2007-10-26
K070743Z6 STIMULATORSt Cardio Technologies, LLC2007-07-02
K041442EP-4 CLINICAL STIMUTATOREp Medsystems2004-09-14
K011826EPS320 CARDIAC STIMULATORMicropace Pty, Ltd.2002-01-24
K991293EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATORFischer Medical Technologies, Inc.2000-05-05
K963579PACE-1A CARDIAC STIMULATORRadionics, Inc.1996-11-08
K935590EP MEDICAL, INC. EP-3 CLINICAL STIMULATOREp Medical, Inc.1994-05-05
K900553CONSTANT CURRENT STIMULATOR MODEL 022101Ep Technologies, Inc.1990-03-13
K893094HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEMHeartware Intl. Corp.1989-10-02
K861368MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATORMedtronic Vascular1986-08-04
K852746EXTERNAL PACEMAKER TELECTRONICS TE200Seamed Corp.1985-09-12
K844815CORDIS ELECTROPHYSIOLOGY STIMULATORCordis Corp.1985-06-11
K851091MEDTRONIC MODEL 5328 PROGRAM-STIMULATORMedtronic Vascular1985-04-16

Legacy Summary#

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FDA Review#

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