FDA 510(k)

Endo 電機 (E-LITE MAX, E-LITE PRO, E-LITE INO)

K 號：K242514 · 2025-04-24

決定日期2025-04-24

產品代碼EKX

諮詢委員會DE

決定相當於

器材摘要

Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Rogin Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K242514. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)?

Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Shenzhen Rogin Medical Co., Ltd.. The 510(k) number is K242514.

When did Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) receive FDA 510(k) clearance?

Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) received FDA 510(k) clearance on 2025-04-24, under 510(k) number K242514.

Who is the listed applicant for Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)?

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

What is the FDA product code for Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)?

The FDA product code for Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) is EKX.

其他以 Shenzhen Rogin Medical Co., Ltd. 為申請人之記錄

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相關器械（代碼：EKX）

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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