FDA 510(k)

肺龍 Chartis 平板控制台

K 號：K180011 · 2018-07-13

決定日期2018-07-13

產品代碼BZG

諮詢委員會AN

決定相當於

器材摘要

Pulmonx Chartis Tablet Console is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonx Corporation. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K180011. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pulmonx Chartis Tablet Console?

Pulmonx Chartis Tablet Console is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Pulmonx Corporation. The 510(k) number is K180011.

When did Pulmonx Chartis Tablet Console receive FDA 510(k) clearance?

Pulmonx Chartis Tablet Console received FDA 510(k) clearance on 2018-07-13, under 510(k) number K180011.

Who is the listed applicant for Pulmonx Chartis Tablet Console?

The FDA 510(k) record lists Pulmonx Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pulmonx Chartis Tablet Console?

The FDA product code for Pulmonx Chartis Tablet Console is BZG.

其他以 Pulmonx Corporation 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。

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相關器械（代碼：BZG）

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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