FDA 510(k)

Altech® Exhalation Valve (Single Limb and Dual Limb)

K号: K210992 · 2021-12-23

决定日期2021-12-23

产品代码CBP

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决定实质等同

器械摘要

Altech® Exhalation Valve (Single Limb and Dual Limb) is the device name listed in this FDA 510(k) record. The listed applicant is Meditera Tibbi Malzeme San VE Tic AS. It received FDA 510(k) clearance on 2021-12-23 under 510(k) number K210992. 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 Altech® Exhalation Valve (Single Limb and Dual Limb)?

Altech® Exhalation Valve (Single Limb and Dual Limb) is a medical device that received FDA 510(k) clearance on 2021-12-23. The listed applicant is Meditera Tibbi Malzeme San VE Tic AS. The 510(k) number is K210992.

When did Altech® Exhalation Valve (Single Limb and Dual Limb) receive FDA 510(k) clearance?

Altech® Exhalation Valve (Single Limb and Dual Limb) received FDA 510(k) clearance on 2021-12-23, under 510(k) number K210992.

Who is the listed applicant for Altech® Exhalation Valve (Single Limb and Dual Limb)?

The FDA 510(k) record lists Meditera Tibbi Malzeme San VE Tic AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Altech® Exhalation Valve (Single Limb and Dual Limb)?

The FDA product code for Altech® Exhalation Valve (Single Limb and Dual Limb) is CBP.

列明Meditera Tibbi Malzeme San VE Tic AS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。

K192713Altera Filter and HME/Filter K192563Altera gas Sampling Lines

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.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.

官方来源

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