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510(k) K852587

Device
CDSA(COLOR DENSITY, SPECTRAL ARRRAY)
Applicant
TRACOR NORTHERN, INC.
510(k) number
K852587
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
1985-08-16
Date received
1985-06-18
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#

Contact
PATTY SONNTAG
Address
2551 W. Beltline Hwy. Middleton WI US 53562 53562

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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