掃描監視器
K 號:K201456 · 2021-10-05
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器材摘要
Scan Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Withings SA. It received FDA 510(k) clearance on 2021-10-05 under 510(k) number K201456. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Scan Monitor?
Scan Monitor is a medical device that received FDA 510(k) clearance on 2021-10-05. The listed applicant is Withings SA. The 510(k) number is K201456.
When did Scan Monitor receive FDA 510(k) clearance?
Scan Monitor received FDA 510(k) clearance on 2021-10-05, under 510(k) number K201456.
Who is the listed applicant for Scan Monitor?
The FDA 510(k) record lists Withings SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Scan Monitor?
The FDA product code for Scan Monitor is DPS.
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相關器械(代碼:DPS)
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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