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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name amplitude-integrated electroencephalograph
510(k) Number K161027
Device Name Cadwell AmpliScan
Applicant
Cadwell Industries, Inc.
909 N. Kellog St.
Kennewick,  WA  99336
Applicant Contact John Cadwell
Correspondent
Cadwell Industries, Inc.
909 N. Kellog St.
Kennewick,  WA  99336
Correspondent Contact John Cadwell
Regulation Number882.1400
Classification Product Code
OMA  
Date Received04/12/2016
Decision Date 11/08/2016
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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