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FDA 510(k)

Trachealator

K-Number: K211894 · 2021-11-24

ApplicantDisa Medinotec
Decision Date2021-11-24
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Trachealator is a medical device manufactured by Disa Medinotec. It received FDA 510(k) clearance on 2021-11-24 under approval number K211894. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Trachealator?

Trachealator is a medical device that received FDA 510(k) clearance on 2021-11-24. It is manufactured by Disa Medinotec. The 510(k) number is K211894.

When was Trachealator approved by the FDA?

Trachealator received FDA 510(k) clearance on 2021-11-24, under approval number K211894.

What company makes Trachealator?

Trachealator is manufactured by Disa Medinotec.

What is the FDA product code for Trachealator?

The FDA product code for Trachealator is KTI.

Other Devices by Disa Medinotec

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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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