FDA 510(k)

一次性血液針

K 號：K223314 · 2023-01-25

申請人Huaian Hening Medical Instruments Co., Ltd.

決定日期2023-01-25

產品代碼QRK

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

Disposable Blood Lancets is the device name listed in this FDA 510(k) record. The listed applicant is Huaian Hening Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-01-25 under 510(k) number K223314. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Blood Lancets?

Disposable Blood Lancets is a medical device that received FDA 510(k) clearance on 2023-01-25. The listed applicant is Huaian Hening Medical Instruments Co., Ltd.. The 510(k) number is K223314.

When did Disposable Blood Lancets receive FDA 510(k) clearance?

Disposable Blood Lancets received FDA 510(k) clearance on 2023-01-25, under 510(k) number K223314.

Who is the listed applicant for Disposable Blood Lancets?

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

What is the FDA product code for Disposable Blood Lancets?

The FDA product code for Disposable Blood Lancets is QRK.

其他以 Huaian Hening Medical Instruments 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。

K223313一次性安全針

相關器械（代碼：QRK）

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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