ICS CHARTR EP 200— 510(k) K083399

Substantially Equivalent

Gn Otometrics A/S

FDA 510(k) clearance K083399 for ICS CHARTR EP 200, Substantially Equivalent on 2009-02-20. Applicant: Gn Otometrics A/S. Device class: 2.

Clearance details

Applicant: Gn Otometrics A/S
Product code: Code GWJ
Device class: Class 2
Regulation: 21 CFR 882.1900
Advisory panel: Neurology
Date received: 2008-11-17
Decision date: 2009-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWJ

K242954 — Integrity V500 (Integrity, Integrity with VEMP)2024-12-19
K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro)2024-03-08
K220139 — QScreen2022-08-03
K211147 — ALGO 7i2021-10-14
K193033 — GSI Audera Pro2020-04-24

More clearances from Gn Otometrics A/S

K143670 — ICS CHARTR EP 200 WITH VEMP2015-10-23
K110286 — GN OTOMETRICS TYPE 1053 FREEFIT2011-04-28
K061791 — FOCUS VNG/ENG TYPE 10682006-07-11
K061104 — SPEECHLINK 100 TYPE 10532006-05-03
K033645 — OTOFLEX 100 TYE 10122004-03-31

Recalls naming K083399

K-number listed on FDA's recall record

Z-0170-2020 — The ICS CHARTR EP 200Class II·Terminated·GN Otometrics·20190528

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083399.

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