AT235— 510(k) K151616

Substantially Equivalent

Interacoustics A/S

FDA 510(k) clearance K151616 for AT235, Substantially Equivalent on 2015-07-15. Applicant: Interacoustics A/S. Device class: 2.

Clearance details

Applicant: Interacoustics A/S
Product code: Code ETY
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 2015-06-15
Decision date: 2015-07-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Assens, DK

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.