510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203331Substantially Equivalent

Quick-20m

CGX, LLC, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203331 is the FDA 510(k) clearance record for Quick-20m, a class II device, cleared for Cgx, LLC on under FDA product code GWL (Amplifier, Physiological Signal). FDA records list one 510(k) clearance for Cgx, LLC. As of , FDA records show no recalls naming K203331.

Clearance record

Decision date
Received
(189 days to decision)
Product code
GWL Amplifier, Physiological Signal
Regulation
21 CFR 882.1835
Device class
Class II
Review panel
Neurology
Applicant
Cgx, LLC 8445 Camino Sante Fe, Suite 104, San Diego CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code GWL

Trailing 12 months

FDA records hold no clearances under product code GWL in the trailing twelve months.

FDA records show no clearances under product code GWL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GWL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260