FDA 510(k)

ベイズヘルス・セプシス・フラッグリング・デバイス

K番号: K250680 · 2026-04-30

決定日2026-04-30

製品コードSAK

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

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.

よくある質問

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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医療機器の概要

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