510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131383Substantially Equivalent

X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software

Advanced Brain Monitoring, Inc., Dousman WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131383 is the FDA 510(k) clearance record for X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE, a class II device, cleared for Advanced Brain Monitoring, Inc. on under FDA product code GWQ (Full-Montage Standard Electroencephalograph). FDA's definition for product code GWQ reads: "Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations". FDA records list 15 510(k) clearances for Advanced Brain Monitoring, Inc., from to . As of , FDA records show no recalls naming K131383.

Clearance record

Decision date
Received
(197 days to decision)
Product code
GWQ Full-Montage Standard Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Advanced Brain Monitoring, Inc. W324 S3649 County Rd. E, Dousman WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWQ

Trailing 12 months
2 clearances under product code GWQ in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260