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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nystagmograph
510(k) Number K010059
Device Name ENGPLUS
Applicant
Western Systems Research, Inc.
260 S. Los Robles Ave. Suite 106
Pasadena,  CA  91101
Applicant Contact LINDA DAVIS-O'LEARY
Correspondent
Western Systems Research, Inc.
260 S. Los Robles Ave. Suite 106
Pasadena,  CA  91101
Correspondent Contact LINDA DAVIS-O'LEARY
Regulation Number882.1460
Classification Product Code
GWN  
Date Received01/08/2001
Decision Date 02/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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