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FDA 510(k)

I-Motion

K 號：K212413 · 2022-05-26

申請人I-Motion Group Global Iberica S.L.
決定日期2022-05-26
產品代碼NGX
諮詢委員會PM
決定相當於

器材摘要

I-Motion is the device name listed in this FDA 510(k) record. The listed applicant is I-Motion Group Global Iberica S.L.. It received FDA 510(k) clearance on 2022-05-26 under 510(k) number K212413. 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 I-Motion?

I-Motion is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is I-Motion Group Global Iberica S.L.. The 510(k) number is K212413.

When did I-Motion receive FDA 510(k) clearance?

I-Motion received FDA 510(k) clearance on 2022-05-26, under 510(k) number K212413.

Who is the listed applicant for I-Motion?

The FDA 510(k) record lists I-Motion Group Global Iberica S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-Motion?

The FDA product code for I-Motion is NGX.

相關臨床試驗

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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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