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.

Clearance details

Applicant: Gn Otometrics A/S
Product code: Code GWJ
Advisory panel: Neurology
Date received: 2014-12-24
Decision date: 2015-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taastrup, DK

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