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FDA 510(k)

Heated Breathing Tube

Número K: K243244 · 2025-07-25

RequerenteGuangdong Eda Technology Co., Ltd.
Data da decisão2025-07-25
Código do produtoBZE
Comité consultivoAN
DecisãoSubstantially Equivalent

Resumo do dispositivo

Heated Breathing Tube is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Eda Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-25 under 510(k) number K243244. 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 Heated Breathing Tube?

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

When did Heated Breathing Tube receive FDA 510(k) clearance?

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

Who is the listed applicant for Heated Breathing Tube?

The FDA 510(k) record lists Guangdong Eda Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Heated Breathing Tube?

The FDA product code for Heated Breathing Tube 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.

K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)Vincent Healthcare Products LimitedK253322Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)Medline Industries, LPK241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron MedicalK234032Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension LineMedline Industries, LPK222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO KgaaK201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.

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