Bayesian Health 败血症标志设备
K号: K250680 · 2026-04-30
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决定日期2026-04-30
产品代码SAK
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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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官方来源
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