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FDA 510(k)

PATI(舌傷防護器)

K 號:K221469 · 2023-02-22

決定日期2023-02-22
產品代碼JXL
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

PATI (Protector Against Tongue Injury) is the device name listed in this FDA 510(k) record. The listed applicant is Neurovice, LLC. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K221469. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PATI (Protector Against Tongue Injury)?

PATI (Protector Against Tongue Injury) is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Neurovice, LLC. The 510(k) number is K221469.

When did PATI (Protector Against Tongue Injury) receive FDA 510(k) clearance?

PATI (Protector Against Tongue Injury) received FDA 510(k) clearance on 2023-02-22, under 510(k) number K221469.

Who is the listed applicant for PATI (Protector Against Tongue Injury)?

The FDA 510(k) record lists Neurovice, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATI (Protector Against Tongue Injury)?

The FDA product code for PATI (Protector Against Tongue Injury) is JXL.

相關臨床試驗

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。

相關器械(代碼:JXL)

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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