MADSEN ACCUSCREEN TYPE 1077— 510(k) K132957

Substantially Equivalent

Gn Otometrics

FDA 510(k) clearance K132957 for MADSEN ACCUSCREEN TYPE 1077, Substantially Equivalent on 2014-02-27. Applicant: Gn Otometrics.

Clearance details

Applicant
Gn Otometrics
Product code
Code GWJ
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Naples, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.