ICS Impulse— 510(k) K151504

Substantially Equivalent

Gn Otometrics

FDA 510(k) clearance K151504 for ICS Impulse, Substantially Equivalent on 2015-11-16. Applicant: Gn Otometrics.

Clearance details

Applicant: Gn Otometrics
Product code: Code GWN
Advisory panel: Neurology
Date received: 2015-06-04
Decision date: 2015-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taastrup, DK

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