FDA 510(k)

PRESS DUO elite, PRESS DUO elite AG

K-Number: K173450 · 2018-02-07

Decision Date2018-02-07

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PRESS DUO elite, PRESS DUO elite AG is a medical device manufactured by Nemoto Kyorindo Co., Ltd.. It received FDA 510(k) clearance on 2018-02-07 under approval number K173450. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESS DUO elite, PRESS DUO elite AG?

PRESS DUO elite, PRESS DUO elite AG is a medical device that received FDA 510(k) clearance on 2018-02-07. It is manufactured by Nemoto Kyorindo Co., Ltd.. The 510(k) number is K173450.

When was PRESS DUO elite, PRESS DUO elite AG approved by the FDA?

PRESS DUO elite, PRESS DUO elite AG received FDA 510(k) clearance on 2018-02-07, under approval number K173450.

What company makes PRESS DUO elite, PRESS DUO elite AG?

PRESS DUO elite, PRESS DUO elite AG is manufactured by Nemoto Kyorindo Co., Ltd..

What is the FDA product code for PRESS DUO elite, PRESS DUO elite AG?

The FDA product code for PRESS DUO elite, PRESS DUO elite AG is DXT.

Other Devices by Nemoto Kyorindo Co., Ltd.

K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

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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.