FDA 510(k)

Xbody 新波美國

K 號：K190038 · 2019-04-05

決定日期2019-04-05

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Xbody Newave USA is the device name listed in this FDA 510(k) record. The listed applicant is Xbody Hungary Kft.. It received FDA 510(k) clearance on 2019-04-05 under 510(k) number K190038. 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 Xbody Newave USA?

Xbody Newave USA is a medical device that received FDA 510(k) clearance on 2019-04-05. The listed applicant is Xbody Hungary Kft.. The 510(k) number is K190038.

When did Xbody Newave USA receive FDA 510(k) clearance?

Xbody Newave USA received FDA 510(k) clearance on 2019-04-05, under 510(k) number K190038.

Who is the listed applicant for Xbody Newave USA?

The FDA 510(k) record lists Xbody Hungary Kft. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xbody Newave USA?

The FDA product code for Xbody Newave USA is NGX.

其他以 Xbody Hungary Kft. 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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