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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name normalizing quantitative electroencephalograph software
510(k) Number K974748
Device Name NEUROMETRIC ANALYSIS SYSTEM
Applicant
NXLINK, LTD.
1706 GAILLARD PL.
richland,  WA  99352 -2624
Applicant Contact duane shuttlesworth
Correspondent
NXLINK, LTD.
1706 GAILLARD PL.
richland,  WA  99352 -2624
Correspondent Contact duane shuttlesworth
Regulation Number882.1400
Classification Product Code
OLU  
Date Received12/19/1997
Decision Date 07/10/1998
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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