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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K924179
Device Name EEG MODEL 24/32
Applicant
Lama Engineering, Inc.
5233 Tyler Ave.
Temple City,  CA  91780
Applicant Contact FENDER
Correspondent
Lama Engineering, Inc.
5233 Tyler Ave.
Temple City,  CA  91780
Correspondent Contact FENDER
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received08/19/1992
Decision Date 06/22/1993
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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