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FDA 510(k)

Facet Manatee 可重用針刺底座

K 號:K223099 · 2022-11-28

決定日期2022-11-28
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 Manatee Reusable Lancing Base 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 2022-11-28 under 510(k) number K223099. 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 Manatee Reusable Lancing Base?

Facet Manatee Reusable Lancing Base is a medical device that received FDA 510(k) clearance on 2022-11-28. The listed applicant is Facet Technologies, LLC. The 510(k) number is K223099.

When did Facet Manatee Reusable Lancing Base receive FDA 510(k) clearance?

Facet Manatee Reusable Lancing Base received FDA 510(k) clearance on 2022-11-28, under 510(k) number K223099.

Who is the listed applicant for Facet Manatee Reusable Lancing Base?

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 Manatee Reusable Lancing Base?

The FDA product code for Facet Manatee Reusable Lancing Base is QRL.

相關臨床試驗

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。

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。

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。

官方來源

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