FDA 510(k)

Freestyle 測血糖針設備 II，Autolet，Autolet Lite，Unilet 鋸針

K 號：K221613 · 2022-10-03

決定日期2022-10-03

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

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets is the device name listed in this FDA 510(k) record. The listed applicant is Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2022-10-03 under 510(k) number K221613. 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 Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets?

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets is a medical device that received FDA 510(k) clearance on 2022-10-03. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K221613.

When did Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets receive FDA 510(k) clearance?

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets received FDA 510(k) clearance on 2022-10-03, under 510(k) number K221613.

Who is the listed applicant for Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets?

The FDA 510(k) record lists Owen Mumford, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets?

The FDA product code for Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets is QRL.

其他以 Owen Mumford, 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。

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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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