FDA 510(k)

MedtFine 安全針刺器

K 號：K241848 · 2024-08-20

申請人Ningbo Caremed Medical Products Co., Ltd.

決定日期2024-08-20

產品代碼FMK

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

MedtFine Safety Lancet 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 2024-08-20 under 510(k) number K241848. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MedtFine Safety Lancet?

MedtFine Safety Lancet is a medical device that received FDA 510(k) clearance on 2024-08-20. The listed applicant is Ningbo Caremed Medical Products Co., Ltd.. The 510(k) number is K241848.

When did MedtFine Safety Lancet receive FDA 510(k) clearance?

MedtFine Safety Lancet received FDA 510(k) clearance on 2024-08-20, under 510(k) number K241848.

Who is the listed applicant for MedtFine Safety Lancet?

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 MedtFine Safety Lancet?

The FDA product code for MedtFine Safety Lancet is FMK.

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。

K242622單次使用无菌針頭刺針

相關器械（代碼：FMK）

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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