510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002985Substantially Equivalent

Ics Medical Chartr Ep and Chartr Oae Systems

Ics Medical Corp., Schaumburg IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002985 is the FDA 510(k) clearance record for ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS, a class II device, cleared for Ics Medical Corp. on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list 12 510(k) clearances for Ics Medical Corp., from to . As of , FDA records show no recalls naming K002985.

Clearance record

Decision date
Received
(79 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Ics Medical Corp. 125 Commerce Dr., Schaumburg IL
510(k) summary
Summary
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