FDA 510(k)

單次使用无菌皮下針頭

K 號：K233037 · 2023-12-12

申請人Zhejiang Kindly Medical Device Co., Ltd.

決定日期2023-12-12

產品代碼FMI

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Sterile Hypodermic Needles for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Kindly Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-12-12 under 510(k) number K233037. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile Hypodermic Needles for Single Use?

Sterile Hypodermic Needles for Single Use is a medical device that received FDA 510(k) clearance on 2023-12-12. The listed applicant is Zhejiang Kindly Medical Device Co., Ltd.. The 510(k) number is K233037.

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

Sterile Hypodermic Needles for Single Use received FDA 510(k) clearance on 2023-12-12, under 510(k) number K233037.

Who is the listed applicant for Sterile Hypodermic Needles for Single Use?

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

What is the FDA product code for Sterile Hypodermic Needles for Single Use?

The FDA product code for Sterile Hypodermic Needles for Single Use is FMI.

其他以 Zhejiang Kindly Medical Device Co., Ltd. 為申請人之記錄

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K252899女性培養設備；男性培養設備；傳送設備；進入設備

相關器械（代碼：FMI）

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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