FDA 510(k)

Xpert PFP

K 號：K261038 · 2026-05-29

決定日期2026-05-29

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Xpert PFP is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K261038. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Xpert PFP?

Xpert PFP is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Newclip Technics. The 510(k) number is K261038.

When did Xpert PFP receive FDA 510(k) clearance?

Xpert PFP received FDA 510(k) clearance on 2026-05-29, under 510(k) number K261038.

Who is the listed applicant for Xpert PFP?

FDA 510(k) 記錄將 Newclip Technics 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Xpert PFP?

The FDA product code for Xpert PFP is HRS.

其他以 Newclip Technics 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。

K261511Xpert 頸部 K261191Alians Elbow S K253906Xpert 手機械設備 K250767Newclip 患者匹配儀器非無菌 PSI K250155Xpert膝 K243912Newclip 患者匹配儀器非無菌 PSI

查看所有 26 項裝置 →

相關器械（代碼：HRS）

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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