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FDA 510(k)

RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR

K-Number: K161345 · 2016-07-06

ApplicantSedecal., Sa.
Decision Date2016-07-06
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Sedecal., Sa.. The 510(k) number is K161345.

When was RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR approved by the FDA?

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

What company makes 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 manufactured by Sedecal., Sa..

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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Related Devices (Code: IZL)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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