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FDA 510(k)

Heated Breathing Tube

K-Number: K243244 · 2025-07-25

ApplicantGuangdong Eda Technology Co., Ltd.
Decision Date2025-07-25
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Heated Breathing Tube is a medical device manufactured by Guangdong Eda Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-25 under approval number K243244. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Heated Breathing Tube?

Heated Breathing Tube is a medical device that received FDA 510(k) clearance on 2025-07-25. It is manufactured by Guangdong Eda Technology Co., Ltd.. The 510(k) number is K243244.

When was Heated Breathing Tube approved by the FDA?

Heated Breathing Tube received FDA 510(k) clearance on 2025-07-25, under approval number K243244.

What company makes Heated Breathing Tube?

Heated Breathing Tube is manufactured by Guangdong Eda Technology Co., Ltd..

What is the FDA product code for Heated Breathing Tube?

The FDA product code for Heated Breathing Tube is BZE.

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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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