Solas OR
K 號：K213691 · 2021-12-22
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器材摘要
Solas OR is the device name listed in this FDA 510(k) record. The listed applicant is Cirdan Imaging, Ltd.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K213691. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Solas OR?
Solas OR is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Cirdan Imaging, Ltd.. The 510(k) number is K213691.
When did Solas OR receive FDA 510(k) clearance?
Solas OR received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213691.
Who is the listed applicant for Solas OR?
The FDA 510(k) record lists Cirdan Imaging, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Solas OR?
The FDA product code for Solas OR is MWP.
相關臨床試驗
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相關器械（代碼：MWP）
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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