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Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)

by Duearity AB

510(k) K223694

Listed No authorization on record

Valid until

Not applicable

No authorization on record

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 7 Oct 2026. What this means

Specification

510(k)

510(k) Number
FDA Product Code
KLW
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 874.3400
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Other devices from Duearity AB

  • Tinearity G1

    Class II

  • Tinearity

    Class IIa