FDA 510(k)

面積血針

K 號：K222539 · 2022-11-18

決定日期2022-11-18

產品代碼QRL

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

Facet Blood Lancets is the device name listed in this FDA 510(k) record. The listed applicant is Facet Technologies, LLC. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K222539. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Facet Blood Lancets?

Facet Blood Lancets is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Facet Technologies, LLC. The 510(k) number is K222539.

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

Facet Blood Lancets received FDA 510(k) clearance on 2022-11-18, under 510(k) number K222539.

Who is the listed applicant for Facet Blood Lancets?

The FDA 510(k) record lists Facet Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Facet Blood Lancets?

The FDA product code for Facet Blood Lancets is QRL.

其他以 Facet Technologies, LLC 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。

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相關器械（代碼：QRL）

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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