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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 the device name listed in this FDA 510(k) record. The listed applicant is Disa Medinotec. It received FDA 510(k) clearance on 2021-11-24 under 510(k) 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. The listed applicant is Disa Medinotec. The 510(k) number is K211894.

When did Trachealator receive FDA 510(k) clearance?

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

Who is the listed applicant for Trachealator?

The FDA 510(k) record lists Disa Medinotec as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trachealator?

The FDA product code for Trachealator is KTI.

Other records listing Disa Medinotec as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KTI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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