FDA 510(k)

Epione

K 號：K211645 · 2022-02-24

決定日期2022-02-24

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

Epione is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Surgical Sas. It received FDA 510(k) clearance on 2022-02-24 under 510(k) number K211645. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Epione?

Epione is a medical device that received FDA 510(k) clearance on 2022-02-24. The listed applicant is Quantum Surgical Sas. The 510(k) number is K211645.

When did Epione receive FDA 510(k) clearance?

Epione received FDA 510(k) clearance on 2022-02-24, under 510(k) number K211645.

Who is the listed applicant for Epione?

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

What is the FDA product code for Epione?

The FDA product code for Epione is JAK.

其他以 Quantum Surgical Sas 為申請人之記錄

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K223758Epione

相關器械（代碼：JAK）

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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