510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874136Substantially Equivalent

Photic Stimulator Models 580-Pscomp,psceeg,psstal

Bio-Logic Systems Corp., Mudelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874136 is the FDA 510(k) clearance record for PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL, a class II device, cleared for Bio-Logic Systems Corp. on under FDA product code GWE (Stimulator, Photic, Evoked Response). FDA records list 57 510(k) clearances for Bio-Logic Systems Corp., from to . As of , FDA records show no recalls naming K874136.

Clearance record

Decision date
Received
(164 days to decision)
Product code
GWE Stimulator, Photic, Evoked Response
Regulation
21 CFR 882.1890
Device class
Class II
Review panel
Neurology
Applicant
Bio-Logic Systems Corp. One Bio-Logic Plz., Mudelein IL
Third party review
No

Clearances, product code GWE

Trailing 12 months

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

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