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FDA 510(k)

朱蒙通用

K 號:K230241 · 2023-02-23

決定日期2023-02-23
產品代碼KPR
諮詢委員會RA
決定相當於

器材摘要

Jumong General is the device name listed in this FDA 510(k) record. The listed applicant is Sg Healthcare Co, Ltd.. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K230241. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Jumong General?

Jumong General is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Sg Healthcare Co, Ltd.. The 510(k) number is K230241.

When did Jumong General receive FDA 510(k) clearance?

Jumong General received FDA 510(k) clearance on 2023-02-23, under 510(k) number K230241.

Who is the listed applicant for Jumong General?

The FDA 510(k) record lists Sg Healthcare Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Jumong General?

The FDA product code for Jumong General is KPR.

相關臨床試驗

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其他以 Sg Healthcare Co, Ltd. 為申請人之記錄

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。

相關器械(代碼:KPR)

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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