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FDA 510(k)

Smartcord, Smartcord X

K-Number: K171577 · 2018-05-03

ApplicantEastdent Co., Ltd.
Decision Date2018-05-03
Product CodeMVL
DecisionSubstantially Equivalent

Device Summary

Smartcord, Smartcord X is a medical device manufactured by Eastdent Co., Ltd.. It received FDA 510(k) clearance on 2018-05-03 under approval number K171577. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smartcord, Smartcord X?

Smartcord, Smartcord X is a medical device that received FDA 510(k) clearance on 2018-05-03. It is manufactured by Eastdent Co., Ltd.. The 510(k) number is K171577.

When was Smartcord, Smartcord X approved by the FDA?

Smartcord, Smartcord X received FDA 510(k) clearance on 2018-05-03, under approval number K171577.

What company makes Smartcord, Smartcord X?

Smartcord, Smartcord X is manufactured by Eastdent Co., Ltd..

What is the FDA product code for Smartcord, Smartcord X?

The FDA product code for Smartcord, Smartcord X is MVL.

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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.

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