ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM— 510(k) K991497

Name: FDA 510(k) clearance K991497
Creator: U.S. Food and Drug Administration
Published: 1999-07-28

Substantially Equivalent

Ics Medical Corp.

FDA 510(k) clearance K991497 for ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM, Substantially Equivalent on 1999-07-28. Applicant: Ics Medical Corp.. Device class: 2.

Clearance details

Applicant: Ics Medical Corp.
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 1999-04-29
Decision date: 1999-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWN

view all

K260566 — SMARTVERTIGO Vestibular Assessment System2026-07-30
K243709 — NeuroEars-Anna2025-08-25
K242198 — ICS Dizcovery (1091)2025-02-14
K242726 — Synapsys VHIT2025-01-03
K223047 — NeuroSwift Pro2023-06-29

More clearances from Ics Medical Corp.

view all

K011181 — ICS MEDICAL CHARTR OAE WITH TYMP2001-06-25
K002985 — ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS2000-12-13
K972631 — ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER1997-09-22
K960097 — CHARTR EP1997-02-21
K931609 — CHARTR ENG SYSTEM1995-09-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.