CoverScan v1
K 號：K212565 · 2022-05-19
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器材摘要
CoverScan v1 is the device name listed in this FDA 510(k) record. The listed applicant is Perspectum, Ltd.. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K212565. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CoverScan v1?
CoverScan v1 is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Perspectum, Ltd.. The 510(k) number is K212565.
When did CoverScan v1 receive FDA 510(k) clearance?
CoverScan v1 received FDA 510(k) clearance on 2022-05-19, under 510(k) number K212565.
Who is the listed applicant for CoverScan v1?
The FDA 510(k) record lists Perspectum, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CoverScan v1?
The FDA product code for CoverScan v1 is LLZ.
相關臨床試驗
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其他以 Perspectum, 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：LLZ）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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