FDA.report

510(k) K844815

Device
Cordis Electrophysiology Stimulator
Applicant
CORDIS CORP.
510(k) number
K844815
Product code
JOQ
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-11
Date received
1984-12-11
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
Traditional
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
DONNA L ROGERS
Address
P.O. Box 025700 Miami FL US 33102 33102

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Other 510(k) Records For Product Code JOQ

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
K040207EP-4 CLINICAL STIMULATOREp Medsystems2004-02-27
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
K851091MEDTRONIC MODEL 5328 PROGRAM-STIMULATORMedtronic Vascular1985-04-16