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FDA 510(k)

Vitaform手術口罩 - 藍色 (Vitaform藍色)；Vitaform手術口罩配護盾 (Vitaform-FS)

K 號：K251902 · 2025-09-17

申請人Vitacore Industries, Inc.
決定日期2025-09-17
產品代碼FXX
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) is the device name listed in this FDA 510(k) record. The listed applicant is Vitacore Industries, Inc.. It received FDA 510(k) clearance on 2025-09-17 under 510(k) number K251902. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)?

Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) is a medical device that received FDA 510(k) clearance on 2025-09-17. The listed applicant is Vitacore Industries, Inc.. The 510(k) number is K251902.

When did Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) receive FDA 510(k) clearance?

Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) received FDA 510(k) clearance on 2025-09-17, under 510(k) number K251902.

Who is the listed applicant for Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)?

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

What is the FDA product code for Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)?

The FDA product code for Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) is FXX.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：FXX）

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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