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FDA 510(k)

史密斯與尼普洛 INTELLIO 平板

K 號:K221929 · 2022-09-06

申請人Smith+Nephew
決定日期2022-09-06
產品代碼ODA
諮詢委員會GU
決定相當於

器材摘要

Smith+Nephew INTELLIO Tablet is the device name listed in this FDA 510(k) record. The listed applicant is Smith+Nephew. It received FDA 510(k) clearance on 2022-09-06 under 510(k) number K221929. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Smith+Nephew INTELLIO Tablet?

Smith+Nephew INTELLIO Tablet is a medical device that received FDA 510(k) clearance on 2022-09-06. The listed applicant is Smith+Nephew. The 510(k) number is K221929.

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

Smith+Nephew INTELLIO Tablet received FDA 510(k) clearance on 2022-09-06, under 510(k) number K221929.

Who is the listed applicant for Smith+Nephew INTELLIO Tablet?

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 INTELLIO Tablet?

The FDA product code for Smith+Nephew INTELLIO Tablet is ODA.

相關臨床試驗

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相關器械(代碼:ODA)

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。

官方來源

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