510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905594Substantially Equivalent

Neurofile Data Storage/accesories to the EEG-4300

Nihon Kohden America Inc, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905594 is the FDA 510(k) clearance record for NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300, a class II device, cleared for Nihon Kohden America, Inc. on under FDA product code GWK (Conditioner, Signal, Physiological). FDA records list 166 510(k) clearances for Nihon Kohden America, Inc., from to . As of , FDA records show no recalls naming K905594.

Clearance record

Decision date
Received
(197 days to decision)
Product code
GWK Conditioner, Signal, Physiological
Regulation
21 CFR 882.1845
Device class
Class II
Review panel
Neurology
Applicant
Nihon Kohden America, Inc. 17112 Armstrong Ave., Irvine CA
Third party review
No

Clearances, product code GWK

Trailing 12 months

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

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