FDA 510(k)

レボリューションアスセンドスライディング

K番号: K233749 · 2024-02-22

決定日2024-02-22

製品コードJAK

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。）

決定大幅同等

医療機器の概要

Revolution Ascend Sliding is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hangwei Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K233749. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Revolution Ascend Sliding?

Revolution Ascend Sliding is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Ge Hangwei Medical Systems Co., Ltd.. The 510(k) number is K233749.

When did Revolution Ascend Sliding receive FDA 510(k) clearance?

Revolution Ascend Sliding received FDA 510(k) clearance on 2024-02-22, under 510(k) number K233749.

Who is the listed applicant for Revolution Ascend Sliding?

The FDA 510(k) record lists Ge Hangwei Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revolution Ascend Sliding?

The FDA product code for Revolution Ascend Sliding is JAK.

申請者としてGe Hangwei Medical Systems Co., Ltd.を記載するその他の記録

K192956自動位置決定装置 K192686Revolution Maxima、Revolution Ace K171013革新型ACT K160131OEC エリートミニビューウェイ

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