FDA 510(k)

Voyant Maryland 熔合設備，單步啟動功能（EB212、EB213、EB214）

K 號：K222284 · 2022-10-14

申請人Applied Medical Resources Corporation

決定日期2022-10-14

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

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官方來源

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