결정일2021-01-29
제품 코드BZE
자문 위원회AN
결정Substantially Equivalent
기기 요약
Sunset Heated CPAP Tube is the device name listed in this FDA 510(k) record. The listed applicant is Sunset Healthcare Solutions, Inc.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K201418. 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 Sunset Heated CPAP Tube?
Sunset Heated CPAP Tube is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Sunset Healthcare Solutions, Inc.. The 510(k) number is K201418.
When did Sunset Heated CPAP Tube receive FDA 510(k) clearance?
Sunset Heated CPAP Tube received FDA 510(k) clearance on 2021-01-29, under 510(k) number K201418.
Who is the listed applicant for Sunset Heated CPAP Tube?
The FDA 510(k) record lists Sunset Healthcare Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sunset Heated CPAP Tube?
The FDA product code for Sunset Heated CPAP 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, LPK243244Heated Breathing TubeGuangdong Eda Technology Co., Ltd.K241268Thermalite 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 Kgaa
공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.