510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K841497Substantially Equivalent

Neuropack 8 Mee 4108

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

K841497 is the FDA 510(k) clearance record for NEUROPACK 8 MEE 4108, 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 K841497.

Clearance record

Decision date
Received
(58 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. 90 Icon St., Foothill 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