FDA 510(k)

EMS雕塑機

K 號：K232982 · 2024-11-25

決定日期2024-11-25

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

EMS Sculpt Machine is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K232982. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EMS Sculpt Machine?

EMS Sculpt Machine is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Shandong Huamei Technology Co., Ltd.. The 510(k) number is K232982.

When did EMS Sculpt Machine receive FDA 510(k) clearance?

EMS Sculpt Machine received FDA 510(k) clearance on 2024-11-25, under 510(k) number K232982.

Who is the listed applicant for EMS Sculpt Machine?

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

What is the FDA product code for EMS Sculpt Machine?

The FDA product code for EMS Sculpt Machine is NGX.

其他以 Shandong Huamei Technology Co., Ltd. 為申請人之記錄

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相關器械（代碼：NGX）

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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