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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 K894276
Device Name CADWELL FREEDOM EEG DEVICE
Applicant
CADWELL LABORATORIES, INC.
909 NORTH KELLOGG ST.
KENNEWICK,  WA  99336
Applicant Contact CARLTON CADWELL
Correspondent
CADWELL LABORATORIES, INC.
909 NORTH KELLOGG ST.
KENNEWICK,  WA  99336
Correspondent Contact CARLTON CADWELL
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received06/23/1989
Decision Date 09/29/1989
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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