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FDA 510(k)

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

Número K: K241268 · 2024-08-02

RequerenteExceleron Medical
Data da decisão2024-08-02
Código do produtoBZE
Comité consultivoAN
DecisãoSubstantially Equivalent

Resumo do dispositivo

Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) is the device name listed in this FDA 510(k) record. The listed applicant is Exceleron Medical. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241268. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Exceleron Medical. The 510(k) number is K241268.

When did Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) receive FDA 510(k) clearance?

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

Who is the listed applicant for Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)?

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

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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Dispositivos Relacionados (Código: BZE)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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