FDA 510(k)

Venue Fit

K番号: K220848 · 2022-06-27

決定日2022-06-27

製品コードIYN

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定Substantially Equivalent

医療機器の概要

Venue Fit is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2022-06-27 under 510(k) number K220848. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Venue Fit?

Venue Fit is a medical device that received FDA 510(k) clearance on 2022-06-27. The listed applicant is GE Medical Systems. The 510(k) number is K220848.

When did Venue Fit receive FDA 510(k) clearance?

Venue Fit received FDA 510(k) clearance on 2022-06-27, under 510(k) number K220848.

Who is the listed applicant for Venue Fit?

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

What is the FDA product code for Venue Fit?

The FDA product code for Venue Fit is IYN.

申請者としてGE Medical Systemsを記載するその他の記録

K253808AIR Recon DL K220851Venue K173341Vivid E80, Vivid E90, Vivid E95

関連機器（コード：IYN）

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