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510(k) K854396

Device
RUB E-Z
Applicant
E-Z INSTRUMENTS CO.
510(k) number
K854396
Product code
GYA  
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-08
Date received
1985-10-31
Regulation
882.1410
Classification name
Tester, Electrode/lead, Electroencephalograph
Medical specialty
Neurology
Review panel
Neurology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KENNETH R HARTMAN
Address
P.O. Box 680263 San Antonio TX US 78268 78268

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GYA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883869DERMTRODEWorld Precision Instruments, Inc.1988-09-30
K830877AP-CHECKGeneral Devices1983-06-08
K820040SC-IT IMPEDANCE TESTERCadwell Laboratories, Inc.1982-01-28
K781475ELECTRODE IMPEDANCE TESTER-MODEL 500Life-Tech Instruments, Inc.1978-09-07

Legacy Summary#

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FDA Review#

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