FDA 510(k)

AS ソフトウェアバージョン Asera

K番号: K260205 · 2026-02-19

決定日2026-02-19

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

AS Software Version Asera is the device name listed in this FDA 510(k) record. The listed applicant is AS Software, LLC. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K260205. 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 AS Software Version Asera?

AS Software Version Asera is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is AS Software, LLC. The 510(k) number is K260205.

When did AS Software Version Asera receive FDA 510(k) clearance?

AS Software Version Asera received FDA 510(k) clearance on 2026-02-19, under 510(k) number K260205.

Who is the listed applicant for AS Software Version Asera?

The FDA 510(k) record lists AS Software, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AS Software Version Asera?

The FDA product code for AS Software Version Asera is LLZ.

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AS ソフトウェアバージョン Asera

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：LLZ）

公式ソース