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510(k) K934050

Device
TOPOGRAPHIC BRAIN MAPPING OPTION
Applicant
BIOSOUND, INC.
510(k) number
K934050
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-03
Date received
1993-08-19
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
WAYNE L NETHERCUTT
Address
7990 Castleway Dr. P.O. Box 50867 Indianapolis IN US 46250 46250

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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