FDA 510(k)

RadPRO® 移动 40kW; RadPRO® 移动 40kW FLEXPLUS，型号 SM-40HF-B-D-VIR

K号: K161345 · 2016-07-06

决定日期2016-07-06

产品代码IZL

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Sedecal., Sa.为申报人的其他记录

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