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FDA 510(k)

神經防護盾

K 號:K220034 · 2023-09-14

決定日期2023-09-14
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

NEUROShield is the device name listed in this FDA 510(k) record. The listed applicant is In-Med Prognostics L3c. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K220034. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NEUROShield?

NEUROShield is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is In-Med Prognostics L3c. The 510(k) number is K220034.

When did NEUROShield receive FDA 510(k) clearance?

NEUROShield received FDA 510(k) clearance on 2023-09-14, under 510(k) number K220034.

Who is the listed applicant for NEUROShield?

The FDA 510(k) record lists In-Med Prognostics L3c as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROShield?

The FDA product code for NEUROShield is LLZ.

相關臨床試驗

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相關器械(代碼:LLZ)

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。

官方來源

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