FDA 510(k)

Unimed CO2 主流模組型號 Capno-M，Unimed CO2 主流模組型號 Capno-M+

K 號：K210019 · 2021-03-04

決定日期2021-03-04

產品代碼CCK

諮詢委員會AN

決定相當於

器材摘要

Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ is the device name listed in this FDA 510(k) record. The listed applicant is Unimed Medical Supplies, Inc.. It received FDA 510(k) clearance on 2021-03-04 under 510(k) number K210019. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+?

Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ is a medical device that received FDA 510(k) clearance on 2021-03-04. The listed applicant is Unimed Medical Supplies, Inc.. The 510(k) number is K210019.

When did Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ receive FDA 510(k) clearance?

Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ received FDA 510(k) clearance on 2021-03-04, under 510(k) number K210019.

Who is the listed applicant for Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+?

The FDA 510(k) record lists Unimed Medical Supplies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+?

The FDA product code for Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ is CCK.

其他以 Unimed Medical Supplies, Inc. 為申請人之記錄

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。

查看所有 13 項裝置 →

相關器械（代碼：CCK）

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。

K251641GF-310R 多氣體單元（GF-310R）Nihon Kohden Corporation K261633視覺呼吸Affirm Medical Technologies II, LLC K253030Capnostream™35 輕便呼吸監測器 (PM35MN)Covidien, LLC K250148醫療氣體分析儀（AG200）Prior Care Science Technology, Ltd.K243956TG-980P 二氧化碳感測器套件（TG-980P）；TG-980P1 二氧化碳感測器套件（TG-980P1）Nihon Kohden Corporation K2512160184 CO2 標本採集管；0184T CO2 標本採集管；0139 CO2 標本採集管；0182 CO2 標本採集管Barbaras Development, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。