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FDA 510(k)

The AVEOtsd (Tongue Stabilizing Device) Mouthpiece

K-Number: K231663 · 2023-09-18

ApplicantInnovative Health Technologies (Nz), Ltd.
Decision Date2023-09-18
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Innovative Health Technologies (Nz), Ltd.. The 510(k) number is K231663.

When was The AVEOtsd (Tongue Stabilizing Device) Mouthpiece approved by the FDA?

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

What company makes The AVEOtsd (Tongue Stabilizing Device) Mouthpiece?

The AVEOtsd (Tongue Stabilizing Device) Mouthpiece is manufactured by Innovative Health Technologies (Nz), Ltd..

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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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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