FDA 510(k)

Altera Filter and HME/Filter

K 號：K192713 · 2020-03-16

決定日期2020-03-16

產品代碼CAH

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

其他以 Meditera Tibbi Malzeme San VE Tic AS 為申請人之記錄

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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