FDA 510(k)

史密斯+尼普萊骨科鏡

K 號：K201349 · 2020-07-20

決定日期2020-07-20

產品代碼HRX

諮詢委員會或

決定相當於

器材摘要

Smith+Nephew Arthroscopes is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew. It received FDA 510(k) clearance on 2020-07-20 under 510(k) number K201349. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Smith+Nephew Arthroscopes?

Smith+Nephew Arthroscopes is a medical device that received FDA 510(k) clearance on 2020-07-20. The listed applicant is Smith & Nephew. The 510(k) number is K201349.

When did Smith+Nephew Arthroscopes receive FDA 510(k) clearance?

Smith+Nephew Arthroscopes received FDA 510(k) clearance on 2020-07-20, under 510(k) number K201349.

Who is the listed applicant for Smith+Nephew Arthroscopes?

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

What is the FDA product code for Smith+Nephew Arthroscopes?

The FDA product code for Smith+Nephew Arthroscopes is HRX.

其他以 Smith & Nephew 為申請人之記錄

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相關器械（代碼：HRX）

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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