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FDA 510(k)

UreTron PF Series Probe

K-Number: K162119 · 2016-08-29

Decision Date2016-08-29
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UreTron PF Series Probe is a medical device manufactured by Med-Sonics Corp.. It received FDA 510(k) clearance on 2016-08-29 under approval number K162119. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UreTron PF Series Probe?

UreTron PF Series Probe is a medical device that received FDA 510(k) clearance on 2016-08-29. It is manufactured by Med-Sonics Corp.. The 510(k) number is K162119.

When was UreTron PF Series Probe approved by the FDA?

UreTron PF Series Probe received FDA 510(k) clearance on 2016-08-29, under approval number K162119.

What company makes UreTron PF Series Probe?

UreTron PF Series Probe is manufactured by Med-Sonics Corp..

What is the FDA product code for UreTron PF Series Probe?

The FDA product code for UreTron PF Series Probe is FFK.

Related Clinical Trials

Other Devices by Med-Sonics Corp.

Related Devices (Code: FFK)

Official Source

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