Madsen Zodiac— 510(k) K161707

Substantially Equivalent

Gn Otometrics

FDA 510(k) clearance K161707 for Madsen Zodiac, Substantially Equivalent on 2016-09-01. Applicant: Gn Otometrics.

Clearance details

Applicant: Gn Otometrics
Product code: Code ETY
Advisory panel: Ear, Nose, Throat
Date received: 2016-06-21
Decision date: 2016-09-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Taastrup, DK

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