FDA 510(k)

ヴォヤント 5mm フュージョンデバイス

K番号: K172624 · 2018-02-13

申請者Applied Medical Resources Corporation

決定日2018-02-13

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Voyant 5mm Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2018-02-13 under 510(k) number K172624. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Voyant 5mm Fusion Device?

Voyant 5mm Fusion Device is a medical device that received FDA 510(k) clearance on 2018-02-13. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K172624.

When did Voyant 5mm Fusion Device receive FDA 510(k) clearance?

Voyant 5mm Fusion Device received FDA 510(k) clearance on 2018-02-13, under 510(k) number K172624.

Who is the listed applicant for Voyant 5mm Fusion Device?

The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Voyant 5mm Fusion Device?

The FDA product code for Voyant 5mm Fusion Device is GEI.

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