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510(k) K800934

Device
R2 ESU CABLE-ADAPTER MODELS 160,161
Applicant
R2 CORP.
510(k) number
K800934
Product code
IKD  
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-20
Date received
1980-04-21
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
K834583CLEAR LEADS-RADIOTRANSPARENT WIRESQuinton, Inc.1984-01-30

Legacy Summary#

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FDA Review#

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