TYPE 1077 ACCUSCREEN— 510(k) K122067

Substantially Equivalent

Gn Otometrics

FDA 510(k) clearance K122067 for TYPE 1077 ACCUSCREEN, Substantially Equivalent on 2012-09-27. Applicant: Gn Otometrics.

Clearance details

Applicant: Gn Otometrics
Product code: Code GWJ
Advisory panel: Neurology
Date received: 2012-07-16
Decision date: 2012-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taastrup, DK

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