510(k) K023536

Device
NUAMPS
Applicant
NEUROSCAN
510(k) number
K023536
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
2003-01-15
Date received
2002-10-21
Regulation
882.1400
Classification name
Non-normalizing Quantitative Electroencephalograph Software
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ELVIRA GARCIA
Address
7850 Paseo Del Norte Suite 101 El Paso TX US 79912 79912

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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