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 the device name listed in this FDA 510(k) record. The listed applicant is Koven Technology, Inc.. It received FDA 510(k) clearance on 2016-05-25 under 510(k) 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. The listed applicant is Koven Technology, Inc.. The 510(k) number is K153762.

When did Smartdop XT6 receive FDA 510(k) clearance?

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

Who is the listed applicant for Smartdop XT6?

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

What is the FDA product code for Smartdop XT6?

The FDA product code for Smartdop XT6 is JOP.

Other records listing Koven Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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