ICS CHARTR EP 200 WITH VEMP— 510(k) K143670

Substantially Equivalent

Gn Otometrics A/S

FDA 510(k) clearance K143670 for ICS CHARTR EP 200 WITH VEMP, Substantially Equivalent on 2015-10-23. 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: 2014-12-24
Decision date: 2015-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taastrup, DK

Download summary PDF View on FDA.gov ↗

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More clearances from Gn Otometrics A/S

K110286 — GN OTOMETRICS TYPE 1053 FREEFIT2011-04-28
K083399 — ICS CHARTR EP 2002009-02-20
K061791 — FOCUS VNG/ENG TYPE 10682006-07-11
K061104 — SPEECHLINK 100 TYPE 10532006-05-03
K033645 — OTOFLEX 100 TYE 10122004-03-31

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