FDA 510(k)

VentStar Resus加热型（N）（MP17030）；VentStar Autobreath加热型（N）（MP17031）

K号: K242769 · 2025-04-04

决定日期2025-04-04

产品代码BTL

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决定实质等同

器械摘要

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) is the device name listed in this FDA 510(k) record. The listed applicant is Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K242769. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)?

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K242769.

When did VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) receive FDA 510(k) clearance?

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K242769.

Who is the listed applicant for VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)?

The FDA 510(k) record lists Draegerwerk AG & CO Kgaa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)?

The FDA product code for VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) is BTL.

列明Draegerwerk AG & CO Kgaa为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253647Evita（V800）；Evita（V600）K222822VentStar Helix 双加热（N）Plus（MP02650），VentStar Helix 加热（N）Plus（MP02608）K222024Evita V800，Evita V600 K222207Babylog VN800, Babylog VN600 K221118CO2 主流传感器 K162821Babyleo TN500

查看所有 7 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。