VS新生兒心脈率監測器
K 號：K201887 · 2021-07-23
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器材摘要
VS Newborn Heart Rate Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Surepulse Medical Limited. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K201887. 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 VS Newborn Heart Rate Monitor?
VS Newborn Heart Rate Monitor is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Surepulse Medical Limited. The 510(k) number is K201887.
When did VS Newborn Heart Rate Monitor receive FDA 510(k) clearance?
VS Newborn Heart Rate Monitor received FDA 510(k) clearance on 2021-07-23, under 510(k) number K201887.
Who is the listed applicant for VS Newborn Heart Rate Monitor?
The FDA 510(k) record lists Surepulse Medical Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VS Newborn Heart Rate Monitor?
The FDA product code for VS Newborn Heart Rate 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
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