FDA 510(k)

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

K号: K241366 · 2024-10-29

决定日期2024-10-29

产品代码CBP

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决定实质等同

器械摘要

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) is the device name listed in this FDA 510(k) record. The listed applicant is Dehas Medical Systems GmbH. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K241366. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)?

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Dehas Medical Systems GmbH. The 510(k) number is K241366.

When did QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) receive FDA 510(k) clearance?

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) received FDA 510(k) clearance on 2024-10-29, under 510(k) number K241366.

Who is the listed applicant for QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)?

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

What is the FDA product code for QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)?

The FDA product code for QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) is CBP.

列明Dehas Medical Systems GmbH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。

K221494Quality Mix Blender, Oxymixer

相关器械（代码：CBP）

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。

K234053F&P Optiflow流量分配器Fisher & Paykel Healthcare, Ltd.K210992Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic AS K192285CPR 面部护盾Firstar Healthcare Company Limited (Guangzhou)K173770OJR215 压力释放歧管Fisher & Paykel Healthcare Limited K171961Compower CPR口罩带氧气端口，Compower CPR口罩不带氧气端口，Compower婴儿CPR口罩，Compower非重复呼吸阀（22mm/15mmOD），非重复呼吸阀（22mm/18.5mm）Xiamen Compower Medical Tech. Co., Ltd.K152521Seal Rite 非重复呼吸阀The Lifeguard Store, Inc.

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