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FDA 510(k)

薩利歐

K 號:K191436 · 2019-10-18

決定日期2019-10-18
產品代碼EGJ
諮詢委員會PM
決定相當於

器材摘要

Saalio is the device name listed in this FDA 510(k) record. The listed applicant is Saalmann Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K191436. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Saalio?

Saalio is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Saalmann Medical GmbH & Co. KG. The 510(k) number is K191436.

When did Saalio receive FDA 510(k) clearance?

Saalio received FDA 510(k) clearance on 2019-10-18, under 510(k) number K191436.

Who is the listed applicant for Saalio?

The FDA 510(k) record lists Saalmann Medical GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Saalio?

The FDA product code for Saalio is EGJ.

相關臨床試驗

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相關器械(代碼:EGJ)

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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