Eclipse PRO
K 號：K211651 · 2021-11-22
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器材摘要
Eclipse PRO is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Healthcare, Ltd.. It received FDA 510(k) clearance on 2021-11-22 under 510(k) number K211651. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Eclipse PRO?
Eclipse PRO is a medical device that received FDA 510(k) clearance on 2021-11-22. The listed applicant is Spacelabs Healthcare, Ltd.. The 510(k) number is K211651.
When did Eclipse PRO receive FDA 510(k) clearance?
Eclipse PRO received FDA 510(k) clearance on 2021-11-22, under 510(k) number K211651.
Who is the listed applicant for Eclipse PRO?
The FDA 510(k) record lists Spacelabs Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Eclipse PRO?
The FDA product code for Eclipse PRO is MWJ.
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其他以 Spacelabs Healthcare, Ltd. 為申請人之記錄
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。
相關器械（代碼：MWJ）
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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