FDA 510(k)

Altera Filter and HME/Filter

K号: K192713 · 2020-03-16

决定日期2020-03-16

产品代码CAH

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决定实质等同

器械摘要

Altera Filter and HME/Filter 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 2020-03-16 under 510(k) number K192713. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Altera Filter and HME/Filter?

Altera Filter and HME/Filter is a medical device that received FDA 510(k) clearance on 2020-03-16. The listed applicant is Meditera Tibbi Malzeme San VE Tic AS. The 510(k) number is K192713.

When did Altera Filter and HME/Filter receive FDA 510(k) clearance?

Altera Filter and HME/Filter received FDA 510(k) clearance on 2020-03-16, under 510(k) number K192713.

Who is the listed applicant for Altera Filter and HME/Filter?

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 Altera Filter and HME/Filter?

The FDA product code for Altera Filter and HME/Filter is CAH.

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。

K210992Altech® Exhalation Valve (Single Limb and Dual Limb)K192563Altera gas Sampling Lines

官方来源

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