呈現
K 號:K211014 · 2021-07-28
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器材摘要
Portray is the device name listed in this FDA 510(k) record. The listed applicant is Surround Medical Systems. It received FDA 510(k) clearance on 2021-07-28 under 510(k) number K211014. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Portray?
Portray is a medical device that received FDA 510(k) clearance on 2021-07-28. The listed applicant is Surround Medical Systems. The 510(k) number is K211014.
When did Portray receive FDA 510(k) clearance?
Portray received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211014.
Who is the listed applicant for Portray?
The FDA 510(k) record lists Surround Medical Systems as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Portray?
The FDA product code for Portray is EHD.
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相關器械(代碼:EHD)
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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