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FDA 510(k)

Smartcord, Smartcord X

K-Number: K171577 · 2018-05-03

Decision Date2018-05-03
Product CodeMVL
DecisionSubstantially Equivalent

Device Summary

Smartcord, Smartcord X is the device name listed in this FDA 510(k) record. The listed applicant is Eastdent Co., Ltd.. It received FDA 510(k) clearance on 2018-05-03 under 510(k) 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. The listed applicant is Eastdent Co., Ltd.. The 510(k) number is K171577.

When did Smartcord, Smartcord X receive FDA 510(k) clearance?

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

Who is the listed applicant for Smartcord, Smartcord X?

The FDA 510(k) record lists Eastdent Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: MVL)

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.

Official Source

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