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510(k) K894889

Device
TECA NEUROMAPPER 386
Applicant
TECA, INC.
510(k) number
K894889
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
1989-12-22
Date received
1989-08-01
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
SCOTT A GRILLO
Address
Three Campus Dr. Pleasantiville NY US 10570 10570

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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