AURICAL HIT— 510(k) K122028

Substantially Equivalent

Gn Otometrics

FDA 510(k) clearance K122028 for AURICAL HIT, Substantially Equivalent on 2012-10-23. Applicant: Gn Otometrics.

Clearance details

Applicant: Gn Otometrics
Product code: Code ETW
Advisory panel: Ear, Nose, Throat
Date received: 2012-07-10
Decision date: 2012-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

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