FDA 510(k)

SM-IV

K 號：K232185 · 2023-08-21

決定日期2023-08-21

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

SM-IV is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2023-08-21 under 510(k) number K232185. 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-IV?

SM-IV is a medical device that received FDA 510(k) clearance on 2023-08-21. The listed applicant is Sedecal., Sa.. The 510(k) number is K232185.

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

SM-IV received FDA 510(k) clearance on 2023-08-21, under 510(k) number K232185.

Who is the listed applicant for SM-IV?

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-IV?

The FDA product code for SM-IV 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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