FDA 510(k)

Soltus 500

K 號：K192936 · 2019-11-15

決定日期2019-11-15

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

Soltus 500 is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K192936. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Soltus 500?

Soltus 500 is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Sedecal., Sa.. The 510(k) number is K192936.

When did Soltus 500 receive FDA 510(k) clearance?

Soltus 500 received FDA 510(k) clearance on 2019-11-15, under 510(k) number K192936.

Who is the listed applicant for Soltus 500?

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

What is the FDA product code for Soltus 500?

The FDA product code for Soltus 500 is IZL.

其他以 Sedecal., Sa. 為申請人之記錄

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相關器械（代碼：IZL）

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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