FDA 510(k)

OJR215 压力释放歧管

K号: K173770 · 2019-04-05

决定日期2019-04-05

产品代码CBP

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决定实质等同

器械摘要

OJR215 Pressure Relief Manifold is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare Limited. It received FDA 510(k) clearance on 2019-04-05 under 510(k) number K173770. 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 OJR215 Pressure Relief Manifold?

OJR215 Pressure Relief Manifold is a medical device that received FDA 510(k) clearance on 2019-04-05. The listed applicant is Fisher & Paykel Healthcare Limited. The 510(k) number is K173770.

When did OJR215 Pressure Relief Manifold receive FDA 510(k) clearance?

OJR215 Pressure Relief Manifold received FDA 510(k) clearance on 2019-04-05, under 510(k) number K173770.

Who is the listed applicant for OJR215 Pressure Relief Manifold?

The FDA 510(k) record lists Fisher & Paykel Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OJR215 Pressure Relief Manifold?

The FDA product code for OJR215 Pressure Relief Manifold is CBP.

列明Fisher & Paykel Healthcare Limited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。

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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。

K241366QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)Dehas Medical Systems GmbH 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)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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