Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)— 510(k) K223694

Name: FDA 510(k) clearance K223694
Creator: U.S. Food and Drug Administration
Published: 2023-06-30

Substantially Equivalent

Duearity AB

FDA 510(k) clearance K223694 for Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042), Substantially Equivalent on 2023-06-30. Applicant: Duearity AB. Device class: 2.

Clearance details

Applicant: Duearity AB
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2022-12-09
Decision date: 2023-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malmo, SE

Download summary PDF View on FDA.gov ↗

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