呼吸中止風險評估系統（Apnea Risk Evaluation System，ARES），型號 620
K 號：K160499 · 2017-04-24
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器材摘要
Apnea Risk Evaluation System (ARES), Model 620 is the device name listed in this FDA 510(k) record. The listed applicant is Watermark Medical. It received FDA 510(k) clearance on 2017-04-24 under 510(k) number K160499. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Apnea Risk Evaluation System (ARES), Model 620?
Apnea Risk Evaluation System (ARES), Model 620 is a medical device that received FDA 510(k) clearance on 2017-04-24. The listed applicant is Watermark Medical. The 510(k) number is K160499.
When did Apnea Risk Evaluation System (ARES), Model 620 receive FDA 510(k) clearance?
Apnea Risk Evaluation System (ARES), Model 620 received FDA 510(k) clearance on 2017-04-24, under 510(k) number K160499.
Who is the listed applicant for Apnea Risk Evaluation System (ARES), Model 620?
The FDA 510(k) record lists Watermark Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Apnea Risk Evaluation System (ARES), Model 620?
The FDA product code for Apnea Risk Evaluation System (ARES), Model 620 is MNR.
相關臨床試驗
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相關器械（代碼：MNR）
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。
官方來源
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