ICS CHARTR EP 200— 510(k) K092373

Substantially Equivalent

Gn Otometrics

FDA 510(k) clearance K092373 for ICS CHARTR EP 200, Substantially Equivalent on 2009-09-03. Applicant: Gn Otometrics. Device class: 2.

Clearance details

Applicant: Gn Otometrics
Product code: Code GWJ
Device class: Class 2
Regulation: 21 CFR 882.1900
Advisory panel: Neurology
Date received: 2009-08-05
Decision date: 2009-09-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Deerfield, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Gn Otometrics

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K151504 — ICS Impulse2015-11-16
K132957 — MADSEN ACCUSCREEN TYPE 10772014-02-27
K122550 — ICS IMPULSE2013-02-01
K122028 — AURICAL HIT2012-10-23

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