FDA 510(k)

安全針刺針

K 號：K253605 · 2026-02-20

決定日期2026-02-20

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

Safety Heel Lancet 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 2026-02-20 under 510(k) number K253605. 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 Safety Heel Lancet?

Safety Heel Lancet is a medical device that received FDA 510(k) clearance on 2026-02-20. The listed applicant is Ningbo Medsun Medical Co., Ltd.. The 510(k) number is K253605.

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

Safety Heel Lancet received FDA 510(k) clearance on 2026-02-20, under 510(k) number K253605.

Who is the listed applicant for Safety Heel Lancet?

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 Safety Heel Lancet?

The FDA product code for Safety Heel Lancet is FMK.

其他以 Ningbo Medsun Medical Co., Ltd. 為申請人之記錄

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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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