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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name amplifier, physiological signal
510(k) Number K203331
Device Name Quick-20m
Applicant
CGX, LLC
8445 Camino Sante Fe, Suite 104
san diego,  CA  92121
Applicant Contact spencer linton
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact prithul bom
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Code
GXY  
Date Received11/12/2020
Decision Date 05/20/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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