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510(k) K834583

Device
CLEAR LEADS-RADIOTRANSPARENT WIRES
Applicant
QUINTON, INC.
510(k) number
K834583
Product code
IKD  
Decision
Substantially Equivalent (SESE)
Decision date
1984-01-30
Date received
1983-12-29
Regulation
890.1175
Classification name
Cable, Electrode
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IKD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K070926ELECTRODE/EXTENSION CABLES, MODELS ATAROscor, Inc.2007-06-07
K992372THE LEADAWAYTherapy Equipment, Inc.1999-10-13
K935260PHYSIOMETRIX CABLE ADAPTER MODIFICATIONPhysiometrix, Inc.1993-12-23
K873361LIFE-SPAN CABLEChemfet Corp.1987-11-09
K800934R2 ESU CABLE-ADAPTER MODELS 160,161R2 Corp.1980-05-20

Legacy Summary#

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FDA Review#

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