Amplifier, Physiological Signal


The following data is part of a premarket notification filed by Cgx, Llc with the FDA for Quick-20m.

Pre-market Notification Details

Device IDK203331
510k NumberK203331
Device Name:Quick-20m
ClassificationAmplifier, Physiological Signal
Applicant CGX, LLC 8445 Camino Sante Fe, Suite 104 San Diego,  CA  92121
ContactSpencer Linton
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeGWL  
CFR Regulation Number882.1835 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-11-12
Decision Date2021-05-20

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