貝葉斯健康細菌性敗血症警示裝置
K 號：K250680 · 2026-04-30
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決定日期2026-04-30
產品代碼SAK
諮詢委員會醫療設備規範文本翻譯如下：
HO
注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於
器材摘要
Bayesian Health Sepsis Flagging Device is the device name listed in this FDA 510(k) record. The listed applicant is Bayesian Health, Inc.. It received FDA 510(k) clearance on 2026-04-30 under 510(k) number K250680. The device is classified under product code SAK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Bayesian Health Sepsis Flagging Device?
Bayesian Health Sepsis Flagging Device is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Bayesian Health, Inc.. The 510(k) number is K250680.
When did Bayesian Health Sepsis Flagging Device receive FDA 510(k) clearance?
Bayesian Health Sepsis Flagging Device received FDA 510(k) clearance on 2026-04-30, under 510(k) number K250680.
Who is the listed applicant for Bayesian Health Sepsis Flagging Device?
The FDA 510(k) record lists Bayesian Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bayesian Health Sepsis Flagging Device?
The FDA product code for Bayesian Health Sepsis Flagging Device is SAK.
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官方來源
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