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FDA 510(k)

Smartdop XT6

K-Number: K153762 · 2016-05-25

Decision Date2016-05-25
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Smartdop XT6 is a medical device manufactured by Koven Technology, Inc.. It received FDA 510(k) clearance on 2016-05-25 under approval number K153762. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smartdop XT6?

Smartdop XT6 is a medical device that received FDA 510(k) clearance on 2016-05-25. It is manufactured by Koven Technology, Inc.. The 510(k) number is K153762.

When was Smartdop XT6 approved by the FDA?

Smartdop XT6 received FDA 510(k) clearance on 2016-05-25, under approval number K153762.

What company makes Smartdop XT6?

Smartdop XT6 is manufactured by Koven Technology, Inc..

What is the FDA product code for Smartdop XT6?

The FDA product code for Smartdop XT6 is JOP.

Other Devices by Koven Technology, Inc.

Related Devices (Code: JOP)

Official Source

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