FDA 510(k)

无菌單次使用自閉針筒（含/不含針）

K 號：K210229 · 2022-02-15

申請人Zhejiang Kangkang Medical-Devices Co., Ltd.

決定日期2022-02-15

產品代碼MEG

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 Auto-Disable Syringes with/without Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Kangkang Medical-Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-02-15 under 510(k) number K210229. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile Auto-Disable Syringes with/without Needle for Single Use?

Sterile Auto-Disable Syringes with/without Needle for Single Use is a medical device that received FDA 510(k) clearance on 2022-02-15. The listed applicant is Zhejiang Kangkang Medical-Devices Co., Ltd.. The 510(k) number is K210229.

When did Sterile Auto-Disable Syringes with/without Needle for Single Use receive FDA 510(k) clearance?

Sterile Auto-Disable Syringes with/without Needle for Single Use received FDA 510(k) clearance on 2022-02-15, under 510(k) number K210229.

Who is the listed applicant for Sterile Auto-Disable Syringes with/without Needle for Single Use?

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

What is the FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use?

The FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use is MEG.

其他以 Zhejiang Kangkang Medical-Devices 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。

K213535單次使用无菌安全針頭 K210232單次使用无菌皮下針頭 K210227單次使用无菌針筒（含/不含針）

相關器械（代碼：MEG）

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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