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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K190760
Device Name Cadwell Bolt Software
Applicant
Cadwell Industries, Inc.
909 N Kellogg St.
Kennewick,  WA  99336
Applicant Contact Emily Whitehead
Correspondent
Cadwell Industries, Inc.
909 N Kellogg St.
Kennewick,  WA  99336
Correspondent Contact Emily Whitehead
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
OMA   ORT  
Date Received03/25/2019
Decision Date 11/23/2019
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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