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FDA 510(k)

RadPRO® 行動式 40kW；RadPRO® 行動式 40kW FLEXPLUS，型號 SM-40HF-B-D-VIR

K 號：K161345 · 2016-07-06

申請人Sedecal., Sa.
決定日期2016-07-06
產品代碼IZL
諮詢委員會RA
決定相當於

器材摘要

RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K161345. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR?

RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is Sedecal., Sa.. The 510(k) number is K161345.

When did RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR receive FDA 510(k) clearance?

RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR received FDA 510(k) clearance on 2016-07-06, under 510(k) number K161345.

Who is the listed applicant for RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR?

The FDA 510(k) record lists Sedecal., Sa. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR?

The FDA product code for RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR is IZL.

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其他以 Sedecal., Sa. 為申請人之記錄

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相關器械（代碼：IZL）

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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