FDA 510(k)

swiftPro系統 (SWF-SPS)；Swift系統 (SWF-SYS)

K 號：K250718 · 2025-08-08

決定日期2025-08-08

產品代碼NEY

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

swiftPro System (SWF-SPS); Swift System (SWF-SYS) is the device name listed in this FDA 510(k) record. The listed applicant is Emblation Limited. It received FDA 510(k) clearance on 2025-08-08 under 510(k) number K250718. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the swiftPro System (SWF-SPS); Swift System (SWF-SYS)?

swiftPro System (SWF-SPS); Swift System (SWF-SYS) is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Emblation Limited. The 510(k) number is K250718.

When did swiftPro System (SWF-SPS); Swift System (SWF-SYS) receive FDA 510(k) clearance?

swiftPro System (SWF-SPS); Swift System (SWF-SYS) received FDA 510(k) clearance on 2025-08-08, under 510(k) number K250718.

Who is the listed applicant for swiftPro System (SWF-SPS); Swift System (SWF-SYS)?

The FDA 510(k) record lists Emblation Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for swiftPro System (SWF-SPS); Swift System (SWF-SYS)?

The FDA product code for swiftPro System (SWF-SPS); Swift System (SWF-SYS) is NEY.

其他以 Emblation Limited 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。

K240518swiftPro™ 系統

相關器械（代碼：NEY）

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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