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FDA 510(k)

安全頭皮靜脈套組,頭皮靜脈套組,血液採集針(頭皮靜脈套組型),血液採集針(針柄型),安全血液採集針(頭皮靜脈套組型),安全血液採集針(針柄型)

K 號:K192681 · 2020-07-28

決定日期2020-07-28
產品代碼FPA
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

Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Kangbao Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2020-07-28 under 510(k) number K192681. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)?

Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) is a medical device that received FDA 510(k) clearance on 2020-07-28. The listed applicant is Jiangsu Kangbao Medical Equipment Co., Ltd.. The 510(k) number is K192681.

When did Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) receive FDA 510(k) clearance?

Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) received FDA 510(k) clearance on 2020-07-28, under 510(k) number K192681.

Who is the listed applicant for Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)?

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

What is the FDA product code for Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)?

The FDA product code for Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) is FPA.

相關臨床試驗

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其他以 Jiangsu Kangbao Medical Equipment 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。

相關器械(代碼:FPA)

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。

官方來源

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