510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991497Substantially Equivalent

Ics Medical Chartr Eng/vng Diagnostic System

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

K991497 is the FDA 510(k) clearance record for ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM, a class II device, cleared for Ics Medical Corp. on under FDA product code GWN (Nystagmograph). FDA records list 12 510(k) clearances for Ics Medical Corp., from to . As of , FDA records show no recalls naming K991497.

Clearance record

Decision date
Received
(90 days to decision)
Product code
GWN Nystagmograph
Regulation
21 CFR 882.1460
Device class
Class II
Review panel
Neurology
Applicant
Ics Medical Corp. 2227 Hammond Dr., Schaumburg IL
510(k) summary
Summary
Third party review
No

Clearances, product code GWN

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