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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K001564
Device Name SCAN LT40 (40 CHANNELS)
Applicant
NEURO SCAN LABS
5700 CROMO DR., SUITE 100
EL PASO,  TX  79912 -5538
Applicant Contact DAVID B JONES
Correspondent
NEURO SCAN LABS
5700 CROMO DR., SUITE 100
EL PASO,  TX  79912 -5538
Correspondent Contact DAVID B JONES
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Code
GWQ  
Date Received05/19/2000
Decision Date 11/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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