EMMa 電子監控管理系統
K 號：K153477 · 2016-05-25
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器材摘要
EMMa Electronic Monitoring Management is the device name listed in this FDA 510(k) record. The listed applicant is Vitasystems GmbH. It received FDA 510(k) clearance on 2016-05-25 under 510(k) number K153477. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EMMa Electronic Monitoring Management?
EMMa Electronic Monitoring Management is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Vitasystems GmbH. The 510(k) number is K153477.
When did EMMa Electronic Monitoring Management receive FDA 510(k) clearance?
EMMa Electronic Monitoring Management received FDA 510(k) clearance on 2016-05-25, under 510(k) number K153477.
Who is the listed applicant for EMMa Electronic Monitoring Management?
The FDA 510(k) record lists Vitasystems GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EMMa Electronic Monitoring Management?
The FDA product code for EMMa Electronic Monitoring Management is DSI.
相關臨床試驗
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相關器械（代碼：DSI）
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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