FDA 510(k)

The AVEOtsd (Tongue Stabilizing Device) Mouthpiece

Número K: K231663 · 2023-09-18

RequerenteInnovative Health Technologies (Nz), Ltd.

Data da decisão2023-09-18

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

The AVEOtsd (Tongue Stabilizing Device) Mouthpiece is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health Technologies (Nz), Ltd.. It received FDA 510(k) clearance on 2023-09-18 under 510(k) number K231663. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the The AVEOtsd (Tongue Stabilizing Device) Mouthpiece?

The AVEOtsd (Tongue Stabilizing Device) Mouthpiece is a medical device that received FDA 510(k) clearance on 2023-09-18. The listed applicant is Innovative Health Technologies (Nz), Ltd.. The 510(k) number is K231663.

When did The AVEOtsd (Tongue Stabilizing Device) Mouthpiece receive FDA 510(k) clearance?

The AVEOtsd (Tongue Stabilizing Device) Mouthpiece received FDA 510(k) clearance on 2023-09-18, under 510(k) number K231663.

Who is the listed applicant for The AVEOtsd (Tongue Stabilizing Device) Mouthpiece?

The FDA 510(k) record lists Innovative Health Technologies (Nz), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The AVEOtsd (Tongue Stabilizing Device) Mouthpiece?

The FDA product code for The AVEOtsd (Tongue Stabilizing Device) Mouthpiece is LRK.

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