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FDA 510(k)

Unistik® 3，无菌單次使用安全針筒；Unistik® 3 Value，无菌單次使用安全針筒；Abbott SF无菌單次使用安全針筒

K 號：K221126 · 2022-08-12

申請人Owen Mumford, Ltd.
決定日期2022-08-12
產品代碼FMK
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

Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety 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 2022-08-12 under 510(k) number K221126. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets?

Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K221126.

When did Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets receive FDA 510(k) clearance?

Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets received FDA 510(k) clearance on 2022-08-12, under 510(k) number K221126.

Who is the listed applicant for Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety 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 Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets?

The FDA product code for Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets is FMK.

相關臨床試驗

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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。

K223854Unistik® ShieldLock, Unistik VacuFlipK231124Unistik® 3 單次使用安全針頭：- 適用 (21G)、標準 (23G)、舒適 (28G)、溫柔 (30G)K222168Unistik TinyTouch 無菌單次使用跟腱切口安全針 - 早產兒及足月兒，Unistik Heelstik 無菌單次使用跟腱切口安全針 - 微早產兒、早產兒、足月兒及嬰兒K222303Unistik® ProK221613Freestyle 測血糖針設備 II，Autolet，Autolet Lite，Unilet 鋸針K222111Unistik Touch 單次使用安全針筒 - 16G、21G、23G、28G 和 30G

查看所有 10 項裝置 →

相關器械（代碼：FMK）

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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