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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Galvanic Skin Response Measurement
510(k) Number K150804
Device Name QBioScan
Applicant
Medeia, Inc.
80 S. W. 8th St. Suite 200
Miami,  FL  33130
Applicant Contact SLAV DANEV
Correspondent
Compliance and Regulatory Services, LLC
3771 Southbrook Dr.
Dayton,  OH  45430
Correspondent Contact DANIEL LEHTONEN
Regulation Number882.1540
Classification Product Code
GZO  
Date Received03/26/2015
Decision Date 10/19/2015
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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