FDA 510(k)

AiORTA - Plan

K 號：K250337 · 2025-10-30

決定日期2025-10-30

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

AiORTA - Plan is the device name listed in this FDA 510(k) record. The listed applicant is ViTAA Medical Solutions, Inc.. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K250337. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AiORTA - Plan?

AiORTA - Plan is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is ViTAA Medical Solutions, Inc.. The 510(k) number is K250337.

When did AiORTA - Plan receive FDA 510(k) clearance?

AiORTA - Plan received FDA 510(k) clearance on 2025-10-30, under 510(k) number K250337.

Who is the listed applicant for AiORTA - Plan?

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

What is the FDA product code for AiORTA - Plan?

The FDA product code for AiORTA - Plan is QIH.

其他以 ViTAA Medical Solutions, Inc. 為申請人之記錄

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K254207AiORTA - Plan v2.0

相關器械（代碼：QIH）

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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