FDA 510(k)

CROMA 電外科電流產生器 (PRD-EMR-050)

K 號：K242983 · 2025-02-05

決定日期2025-02-05

產品代碼GEI

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

CROMA Electrosurgical Generator (PRD-EMR-050) is the device name listed in this FDA 510(k) record. The listed applicant is Creo Medical, Ltd.. It received FDA 510(k) clearance on 2025-02-05 under 510(k) number K242983. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CROMA Electrosurgical Generator (PRD-EMR-050)?

CROMA Electrosurgical Generator (PRD-EMR-050) is a medical device that received FDA 510(k) clearance on 2025-02-05. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K242983.

When did CROMA Electrosurgical Generator (PRD-EMR-050) receive FDA 510(k) clearance?

CROMA Electrosurgical Generator (PRD-EMR-050) received FDA 510(k) clearance on 2025-02-05, under 510(k) number K242983.

Who is the listed applicant for CROMA Electrosurgical Generator (PRD-EMR-050)?

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

What is the FDA product code for CROMA Electrosurgical Generator (PRD-EMR-050)?

The FDA product code for CROMA Electrosurgical Generator (PRD-EMR-050) is GEI.

其他以 Creo Medical, Ltd. 為申請人之記錄

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相關器械（代碼：GEI）

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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