FDA 510(k)

BAC

K 號：K254131 · 2026-05-21

決定日期2026-05-21

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

BAC is the device name listed in this FDA 510(k) record. The listed applicant is DeepHealth, Inc.. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K254131. 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 BAC?

BAC is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is DeepHealth, Inc.. The 510(k) number is K254131.

When did BAC receive FDA 510(k) clearance?

BAC received FDA 510(k) clearance on 2026-05-21, under 510(k) number K254131.

Who is the listed applicant for BAC?

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

What is the FDA product code for BAC?

The FDA product code for BAC is QIH.

其他以 DeepHealth, Inc. 為申請人之記錄

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K253825Saige-Dx K251873Saige-Dx K243703TechLive 醫療設備規範文本翻譯： TechLive 注意事項： 1. 保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址。 2. 遵循政策：medical-regulatory-v1。K243705Saige-Density (2.5.0)K243688Saige-Dx (3.1.0)K241747Saige-Dx

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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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