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510(k) K810359

Device
ELECTROENCEPHALOMYOGRAPH
Applicant
THORACEL RESEARCH LABS.
510(k) number
K810359
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-13
Date received
1981-02-10
Regulation
882.1400
Classification name
Non-normalizing Quantitative Electroencephalograph Software
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

Legacy Summary#

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FDA Review#

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