510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925735Substantially Equivalent

EEG Analyzer

Bio-Scan, Inc., Lancaster TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925735 is the FDA 510(k) clearance record for EEG ANALYZER, a class I device, cleared for Bio-Scan, Inc. on under FDA product code GWS (Analyzer, Spectrum, Electroencephalogram Signal). FDA records list 7 510(k) clearances for Bio-Scan, Inc., from to . As of , FDA records show no recalls naming K925735.

Clearance record

Decision date
Received
(385 days to decision)
Product code
GWS Analyzer, Spectrum, Electroencephalogram Signal
Regulation
21 CFR 882.1420
Device class
Class I
Review panel
Neurology
Applicant
Bio-Scan, Inc. 3200 Pleasant Run Rd., Lancaster TX
510(k) summary
Statement
Third party review
No

Clearances, product code GWS

Trailing 12 months

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

FDA records show no clearances under product code GWS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GWS, 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