V12 PRO
K 號：K210913 · 2021-08-04
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器材摘要
V12 PRO is the device name listed in this FDA 510(k) record. The listed applicant is Slk Medical GmbH. It received FDA 510(k) clearance on 2021-08-04 under 510(k) number K210913. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the V12 PRO?
V12 PRO is a medical device that received FDA 510(k) clearance on 2021-08-04. The listed applicant is Slk Medical GmbH. The 510(k) number is K210913.
When did V12 PRO receive FDA 510(k) clearance?
V12 PRO received FDA 510(k) clearance on 2021-08-04, under 510(k) number K210913.
Who is the listed applicant for V12 PRO?
The FDA 510(k) record lists Slk Medical GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for V12 PRO?
The FDA product code for V12 PRO is IRP.
其他以 Slk Medical GmbH 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：IRP）
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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