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

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.

Clearance details

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

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