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510(k) K953799

Device
DG EXAMINER PLUS
Applicant
MEDELEC LTD.
510(k) number
K953799
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
1995-11-08
Date received
1995-08-14
Regulation
882.1400
Classification name
Non-normalizing Quantitative Electroencephalograph Software
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEFF HALL
Address
Manor Way Old Woking, Surrey DE GU22 9JU GU22 9JU

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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