FDA 510(k)

單次使用无菌針頭刺針

K 號：K242622 · 2024-10-28

申請人Ningbo Caremed Medical Products Co., Ltd.

決定日期2024-10-28

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

Sterile Lancets for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Caremed Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2024-10-28 under 510(k) number K242622. 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 Sterile Lancets for Single Use?

Sterile Lancets for Single Use is a medical device that received FDA 510(k) clearance on 2024-10-28. The listed applicant is Ningbo Caremed Medical Products Co., Ltd.. The 510(k) number is K242622.

When did Sterile Lancets for Single Use receive FDA 510(k) clearance?

Sterile Lancets for Single Use received FDA 510(k) clearance on 2024-10-28, under 510(k) number K242622.

Who is the listed applicant for Sterile Lancets for Single Use?

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

What is the FDA product code for Sterile Lancets for Single Use?

The FDA product code for Sterile Lancets for Single Use is QRK.

其他以 Ningbo Caremed Medical Products 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。

K241848MedtFine 安全針刺器

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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