Sempulse 銀河生命徵象監測器
K 號：K232495 · 2024-05-16
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器材摘要
Sempulse Halo Vital Signs Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Sempulse Corporation. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K232495. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Sempulse Halo Vital Signs Monitor?
Sempulse Halo Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Sempulse Corporation. The 510(k) number is K232495.
When did Sempulse Halo Vital Signs Monitor receive FDA 510(k) clearance?
Sempulse Halo Vital Signs Monitor received FDA 510(k) clearance on 2024-05-16, under 510(k) number K232495.
Who is the listed applicant for Sempulse Halo Vital Signs Monitor?
The FDA 510(k) record lists Sempulse Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sempulse Halo Vital Signs Monitor?
The FDA product code for Sempulse Halo Vital Signs Monitor is DQA.
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相關器械（代碼：DQA）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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