FDA 510(k)

威爾奇艾倫 Connex 生化指標監測器，威爾奇艾倫 Connex 集成式牆壁系統，901060 生化指標監測器

K 號：K171621 · 2017-06-30

決定日期2017-06-30

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2017-06-30 under 510(k) number K171621. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor?

Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K171621.

When did Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor receive FDA 510(k) clearance?

Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor received FDA 510(k) clearance on 2017-06-30, under 510(k) number K171621.

Who is the listed applicant for Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor?

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

What is the FDA product code for Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor?

The FDA product code for Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor is MHX.

其他以 Welch Allyn, Inc. 為申請人之記錄

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K243598威爾奇艾倫 Connex® 360 （多個）K241411威爾奇艾倫Connex® Spot Monitor；901058生命徵象監測器核心（CSM）K223381iExaminer System with Panoptic Plus K212473威爾奇艾倫 Connex 中心站 K191013威爾奇艾倫診斷心臟學套件 2.X.X 內含肺功能檢查選項 K181016Welch Allyn RetinaVue 網路參考編號 901108 PACS 医學影像系統

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相關器械（代碼：MHX）

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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官方來源

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