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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Duearity AB. It received FDA 510(k) clearance on 2023-06-30 under 510(k) 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. The listed applicant is Duearity AB. The 510(k) number is K223694.

When did Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) receive FDA 510(k) clearance?

Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) received FDA 510(k) clearance on 2023-06-30, under 510(k) number K223694.

Who is the listed applicant for Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)?

The FDA 510(k) record lists Duearity AB as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: KLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260413Levo Gen 2 Tinnitus Therapy SystemLevo Medical CorporationK260614Tinnitus TherapySivantos GmbHK233435Peace N Quiet (0.7.0)Pnq HealthK221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbHK201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc.

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.

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