FDA 510(k)

DEKA 草莓

K 號：K233473 · 2024-05-16

決定日期2024-05-16

產品代碼ONF

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

DEKA LOTUS is the device name listed in this FDA 510(k) record. The listed applicant is El.En S.P.A.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K233473. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DEKA LOTUS?

DEKA LOTUS is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is El.En S.P.A.. The 510(k) number is K233473.

When did DEKA LOTUS receive FDA 510(k) clearance?

DEKA LOTUS received FDA 510(k) clearance on 2024-05-16, under 510(k) number K233473.

Who is the listed applicant for DEKA LOTUS?

The FDA 510(k) record lists El.En S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA LOTUS?

The FDA product code for DEKA LOTUS is ONF.

其他以 El.En S.P.A. 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。

K260647規範化醫療設備名稱：SPECCHIO K251432Olo K243683德卡藍光束 K250281DEKA 草莓 K241459MOTUS PRO 系列 K240752DEKA TORO

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相關器械（代碼：ONF）

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。

K261204強烈脈衝光療法設備Sanhe LEFIS Electronics Co., Ltd.K251545強烈脈衝光療法設備（MMABM-1）Micowey Medical Equipment (Guangxi) Co., Ltd.K231952醫療設備名稱：MEDILIGHTMedicreations, LLC K243123IPL治療設備（MDSQMC-01）Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA 草莓El.En S.P.A.K242440強烈脈衝光治療系統（LK-PT）Nanjing Bestview Laser S&T Co., Ltd.

官方來源

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