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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 K231457
Device Name SPARK Scan
Applicant
Spark Neuro, Inc.
212 W. 18th St., Unit 17a
New York,  NY  10011
Applicant Contact Marinela Gombosev
Correspondent
MCRA, LLC
803 7th Steet, NW
Washington,  DC  20001
Correspondent Contact John Doucet
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received05/19/2023
Decision Date 08/18/2023
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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