510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083399Substantially Equivalent

Ics Chartr Ep 200

Natus Medical Denmark ApS, Schaumburg IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083399 is the FDA 510(k) clearance record for ICS CHARTR EP 200, a class II device, cleared for Gn Otometrics A/S on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list 15 510(k) clearances for Natus Medical Denmark ApS, from to . As of , FDA records show one recall naming K083399.

Clearance record

Decision date
Received
(95 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Gn Otometrics A/S 125 Commerce Dr., Schaumburg IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWJ

Trailing 12 months

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

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