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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 K201819
Device Name Cadwell Apollo System
Applicant
Cadwell Industries, Inc.
909 N Kellogg St.
Kennewick,  WA  99336
Applicant Contact Brad Weeks
Correspondent
Cadwell Industries, Inc.
909 N Kellogg St.
Kennewick,  WA  99336
Correspondent Contact Brad Weeks
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GWE   GWL   OLT   OLV   OMC  
Date Received07/01/2020
Decision Date 09/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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