결정일2025-07-25
제품 코드BZE
자문 위원회AN
결정Substantially Equivalent
기기 요약
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.
자주 묻는 질문
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.
관련 임상시험
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
관련 기기 (코드: BZE)
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
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.
공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.