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510(k) K982351

Device
LUNA
Applicant
STELLATE SYSTEMS
510(k) number
K982351
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
1998-07-29
Date received
1998-07-06
Regulation
882.1400
Classification name
Non-normalizing Quantitative Electroencephalograph Software
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GEORGE PAPAGIANNIS
Address
345 Victoria Ave., Suite 505 Westmount, Quebec, Canada, H32 2n2 CA

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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