FDA 510(k)

SM-V

K 號：K222951 · 2022-11-21

決定日期2022-11-21

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

SM-V is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K222951. 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 SM-V?

SM-V is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Sedecal., Sa.. The 510(k) number is K222951.

When did SM-V receive FDA 510(k) clearance?

SM-V received FDA 510(k) clearance on 2022-11-21, under 510(k) number K222951.

Who is the listed applicant for SM-V?

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 SM-V?

The FDA product code for SM-V 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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