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FDA 510(k)

TrachCuff Cuff Controller

K-Number: K220854 · 2023-04-14

ApplicantAw Technologies Aps
Decision Date2023-04-14
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TrachCuff Cuff Controller is a medical device manufactured by Aw Technologies Aps. It received FDA 510(k) clearance on 2023-04-14 under approval number K220854. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TrachCuff Cuff Controller?

TrachCuff Cuff Controller is a medical device that received FDA 510(k) clearance on 2023-04-14. It is manufactured by Aw Technologies Aps. The 510(k) number is K220854.

When was TrachCuff Cuff Controller approved by the FDA?

TrachCuff Cuff Controller received FDA 510(k) clearance on 2023-04-14, under approval number K220854.

What company makes TrachCuff Cuff Controller?

TrachCuff Cuff Controller is manufactured by Aw Technologies Aps.

What is the FDA product code for TrachCuff Cuff Controller?

The FDA product code for TrachCuff Cuff Controller is BSK.

Related Devices (Code: BSK)

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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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