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FDA 510(k)

N2:N2 (注意:原文中未提供具体的医疗设备名称或相关文本,因此翻译为“N2”以保持原文样貌。)

K 號:K240754 · 2024-03-21

決定日期2024-03-21
產品代碼EIA
諮詢委員會DE
決定相當於

器材摘要

N2 is the device name listed in this FDA 510(k) record. The listed applicant is Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2024-03-21 under 510(k) number K240754. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the N2?

N2 is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is Megagen Implant Co., Ltd.. The 510(k) number is K240754.

When did N2 receive FDA 510(k) clearance?

N2 received FDA 510(k) clearance on 2024-03-21, under 510(k) number K240754.

Who is the listed applicant for N2?

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

What is the FDA product code for N2?

The FDA product code for N2 is EIA.

其他以 Megagen Implant Co., Ltd. 為申請人之記錄

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相關器械(代碼:EIA)

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官方來源

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