FDA 510(k)

アバター・メディカル・ソフトウェア V1

K番号: K222035 · 2023-05-24

決定日2023-05-24

製品コードLLZ

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

Avatar Medical Software V1 is the device name listed in this FDA 510(k) record. The listed applicant is Avatar Medical. It received FDA 510(k) clearance on 2023-05-24 under 510(k) number K222035. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Avatar Medical Software V1?

Avatar Medical Software V1 is a medical device that received FDA 510(k) clearance on 2023-05-24. The listed applicant is Avatar Medical. The 510(k) number is K222035.

When did Avatar Medical Software V1 receive FDA 510(k) clearance?

Avatar Medical Software V1 received FDA 510(k) clearance on 2023-05-24, under 510(k) number K222035.

Who is the listed applicant for Avatar Medical Software V1?

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

What is the FDA product code for Avatar Medical Software V1?

The FDA product code for Avatar Medical Software V1 is LLZ.

申請者としてAvatar Medicalを記載するその他の記録

K253950アバター・メディカル・ビジョン K252665brAIn™肩位調整装置 K243292brAIn™肩位調整装置

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