皮亞盾 銀河
K 號：K192411 · 2020-07-02
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器材摘要
Psoria-Shield AURORA is the device name listed in this FDA 510(k) record. The listed applicant is Psoria-Shield. It received FDA 510(k) clearance on 2020-07-02 under 510(k) number K192411. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Psoria-Shield AURORA?
Psoria-Shield AURORA is a medical device that received FDA 510(k) clearance on 2020-07-02. The listed applicant is Psoria-Shield. The 510(k) number is K192411.
When did Psoria-Shield AURORA receive FDA 510(k) clearance?
Psoria-Shield AURORA received FDA 510(k) clearance on 2020-07-02, under 510(k) number K192411.
Who is the listed applicant for Psoria-Shield AURORA?
The FDA 510(k) record lists Psoria-Shield as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Psoria-Shield AURORA?
The FDA product code for Psoria-Shield AURORA is FTC.
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相關器械（代碼：FTC）
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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