510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K950208Substantially Equivalent

Nihon Kohden Neuropack Sigma Meb-5500A Evoked Response & EMG Measuring System

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

K950208 is the FDA 510(k) clearance record for NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM, a class II device, cleared for Nihon Kohden America, Inc. on under FDA product code GWF (Stimulator, Electrical, Evoked Response). FDA records list 166 510(k) clearances for Nihon Kohden America, Inc., from to . As of , FDA records show no recalls naming K950208.

Clearance record

Decision date
Received
(112 days to decision)
Product code
GWF Stimulator, Electrical, Evoked Response
Regulation
21 CFR 882.1870
Device class
Class II
Review panel
Neurology
Applicant
Nihon Kohden America, Inc. 2601 Campus Dr., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code GWF

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