Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)
K-Number: K223694 · 2023-06-30
ApplicantDuearity AB
Decision Date2023-06-30
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) is a medical device manufactured by Duearity AB. It received FDA 510(k) clearance on 2023-06-30 under approval number K223694. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)?
Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) is a medical device that received FDA 510(k) clearance on 2023-06-30. It is manufactured by Duearity AB. The 510(k) number is K223694.
When was Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) approved by the FDA?
Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) received FDA 510(k) clearance on 2023-06-30, under approval number K223694.
What company makes Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)?
Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) is manufactured by Duearity AB.
What is the FDA product code for Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)?
The FDA product code for Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) is KLW.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.