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510(k) K871986

Device
MODEL 5600B PROGRAMMER, PACEMAKER
Applicant
TELECTRONICS, INC.
510(k) number
K871986
Product code
KRG  
Decision
Substantially Equivalent (SESE)
Decision date
1987-06-24
Date received
1987-05-22
Regulation
870.3700
Classification name
Programmer, Pacemaker
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
3
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM C NEALON
Address
40 Crane Hill Rd. Suffield CT US 06078 06078

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KRG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933278INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04Intermedics, Inc.1995-03-15
K884522MODEL 5650 OPTIMATE PERSONAL PROGRAMMERTeletronics, Inc.1989-08-25
K880738MODEL 2331T PATIENT PROGRAMMERMedtronic Vascular1988-11-17
K882429MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004Tpl-Cordis, Inc.1988-07-22
K864712MODEL 1740 PERSONAL POCKET PROGRAMMERTelectronics, Inc.1987-12-17
K863046ULTRA SOFTWARE MODULE: MODEL 2016Cardiac Pacemakers, Inc.1986-12-05
K863045PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580Cardiac Pacemakers, Inc.1986-09-29
K860584SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GENCardiac Pacemakers, Inc.1986-06-06
K860546DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37Pacesetter Systems1986-04-23
K844484HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEAVitatron Medical BV1985-07-24
K844483TP 1Vitatron Medical BV1985-04-19
K844485CERYX6, 611, CERYX 3 311 & CERYX 1 111Vitatron Medical BV1985-04-19
K842364HANDHELD PACEMAKER PROGRAMMER & SOFTWARCardiac Pacemakers, Inc.1984-09-24
K820230PACEMAKER PROGRAMMER 2030Cardiac Pacemakers, Inc.1982-03-15
K812761FLOW-DIRECTED BALLOON THERMODILUTIONNova Medical Specialties1981-11-02

Legacy Summary#

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FDA Review#

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