FDA 510(k)

Voyant Maryland Fusionデバイス（一歩でアクティベーション、EB212、EB213、EB214）

K番号: K222284 · 2022-10-14

申請者Applied Medical Resources Corporation

決定日2022-10-14

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 Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) 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 2022-10-14 under 510(k) number K222284. 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 Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)?

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K222284.

When did Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) receive FDA 510(k) clearance?

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) received FDA 510(k) clearance on 2022-10-14, under 510(k) number K222284.

Who is the listed applicant for Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)?

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 Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)?

The FDA product code for Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) is GEI.

申請者としてApplied Medical Resources Corporationを記載するその他の記録

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