FDA 510(k)

自動定位

K 號：K192956 · 2020-01-16

決定日期2020-01-16

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

Auto Positioning is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hangwei Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2020-01-16 under 510(k) number K192956. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Auto Positioning?

Auto Positioning is a medical device that received FDA 510(k) clearance on 2020-01-16. The listed applicant is Ge Hangwei Medical Systems Co., Ltd.. The 510(k) number is K192956.

When did Auto Positioning receive FDA 510(k) clearance?

Auto Positioning received FDA 510(k) clearance on 2020-01-16, under 510(k) number K192956.

Who is the listed applicant for Auto Positioning?

The FDA 510(k) record lists Ge Hangwei Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Auto Positioning?

The FDA product code for Auto Positioning is JAK.

其他以 Ge Hangwei Medical Systems Co., Ltd. 為申請人之記錄

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相關器械（代碼：JAK）

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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