FDA 510(k)

NeatNick 足跟安全針

K 號：K223370 · 2023-02-13

決定日期2023-02-13

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

NeatNick Heel Safety Lancet 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 2023-02-13 under 510(k) number K223370. 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 NeatNick Heel Safety Lancet?

NeatNick Heel Safety Lancet is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Facet Technologies, LLC. The 510(k) number is K223370.

When did NeatNick Heel Safety Lancet receive FDA 510(k) clearance?

NeatNick Heel Safety Lancet received FDA 510(k) clearance on 2023-02-13, under 510(k) number K223370.

Who is the listed applicant for NeatNick Heel Safety Lancet?

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 NeatNick Heel Safety Lancet?

The FDA product code for NeatNick Heel Safety Lancet is FMK.

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。

K232912Facet Aurora 可重用針頭底座 K223099Facet Manatee 可重用針刺底座 K222539面積血針 K221433Facet 28G 開放式針頭

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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