510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801604Substantially Equivalent

Pathfinder Electrodiagnostic System

Nicolet Biomedical Instruments, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801604 is the FDA 510(k) clearance record for PATHFINDER ELECTRODIAGNOSTIC SYSTEM, a class II device, cleared for Nicolet Biomedical Instruments on under FDA product code GWK (Conditioner, Signal, Physiological). FDA records list 26 510(k) clearances for Nicolet Biomedical Instruments, from to . As of , FDA records show no recalls naming K801604.

Clearance record

Decision date
Received
(21 days to decision)
Product code
GWK Conditioner, Signal, Physiological
Regulation
21 CFR 882.1845
Device class
Class II
Review panel
Neurology
Applicant
Nicolet Biomedical Instruments 803 N. Front St. Suite 3, Mchenry IL
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