FDA 510(k)

穿刺系統

K 號：K232330 · 2024-01-04

決定日期2024-01-04

產品代碼QRK

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Lancing System is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Medsun Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-01-04 under 510(k) number K232330. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lancing System?

Lancing System is a medical device that received FDA 510(k) clearance on 2024-01-04. The listed applicant is Ningbo Medsun Medical Co., Ltd.. The 510(k) number is K232330.

When did Lancing System receive FDA 510(k) clearance?

Lancing System received FDA 510(k) clearance on 2024-01-04, under 510(k) number K232330.

Who is the listed applicant for Lancing System?

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

What is the FDA product code for Lancing System?

The FDA product code for Lancing System is QRK.

其他以 Ningbo Medsun Medical 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。

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相關器械（代碼：QRK）

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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官方來源

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