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510(k) K191322

Device
E-EEGX, N-EEGX
Applicant
GE Healthcare Finland Oy
510(k) number
K191322
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
2020-01-22
Date received
2019-05-15
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
Joel Kent
Address
Kuortaneenkatu 2 Helsinki FI FI-00510 FI-00510

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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