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510(k) K832067

Device
SHARE INT'L TDM
Applicant
SHARE INT'L
510(k) number
K832067
Product code
HCJ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-27
Date received
1983-06-27
Regulation
882.1560
Classification name
Device, Skin Potential Measurement
Medical specialty
Neurology
Review panel
Neurology
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 HCJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K823194SKIN GALVANOMETERSpelson Research Laboratories, Inc.1983-01-21

Legacy Summary#

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FDA Review#

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