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FDA 510(k)

Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)

K-Number: K241268 · 2024-08-02

ApplicantExceleron Medical
Decision Date2024-08-02
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) is a medical device manufactured by Exceleron Medical. It received FDA 510(k) clearance on 2024-08-02 under approval number K241268. 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 Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)?

Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) is a medical device that received FDA 510(k) clearance on 2024-08-02. It is manufactured by Exceleron Medical. The 510(k) number is K241268.

When was Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) approved by the FDA?

Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) received FDA 510(k) clearance on 2024-08-02, under approval number K241268.

What company makes Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)?

Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) is manufactured by Exceleron Medical.

What is the FDA product code for Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)?

The FDA product code for Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) 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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