FDA 510(k)

單次使用細胞學刷

K 號：K220063 · 2022-07-28

申請人Zhejiang Chuangxiang Medical Technology Co., Ltd.

決定日期2022-07-28

產品代碼FDX

諮詢委員會GU

決定相當於

器材摘要

Single Use Cytology Brush is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-28 under 510(k) number K220063. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Single Use Cytology Brush?

Single Use Cytology Brush is a medical device that received FDA 510(k) clearance on 2022-07-28. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K220063.

When did Single Use Cytology Brush receive FDA 510(k) clearance?

Single Use Cytology Brush received FDA 510(k) clearance on 2022-07-28, under 510(k) number K220063.

Who is the listed applicant for Single Use Cytology Brush?

FDA 510(k) 記錄將浙江創想醫療技術有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Single Use Cytology Brush?

The FDA product code for Single Use Cytology Brush is FDX.

其他以 Zhejiang Chuangxiang Medical Technology Co., Ltd. 為申請人之記錄

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相關器械（代碼：FDX）

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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