AlertWatch：OR
K 號：K153335 · 2016-03-15
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器材摘要
AlertWatch: OR is the device name listed in this FDA 510(k) record. The listed applicant is Alertwatch, LLC. It received FDA 510(k) clearance on 2016-03-15 under 510(k) number K153335. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AlertWatch: OR?
AlertWatch: OR is a medical device that received FDA 510(k) clearance on 2016-03-15. The listed applicant is Alertwatch, LLC. The 510(k) number is K153335.
When did AlertWatch: OR receive FDA 510(k) clearance?
AlertWatch: OR received FDA 510(k) clearance on 2016-03-15, under 510(k) number K153335.
Who is the listed applicant for AlertWatch: OR?
The FDA 510(k) record lists Alertwatch, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AlertWatch: OR?
The FDA product code for AlertWatch: OR is MWI.
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相關器械（代碼：MWI）
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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