FDA 510(k)

Annalise Enterprise

K番号: K253818 · 2026-03-03

決定日2026-03-03

製品コードQAS

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

Annalise Enterprise is the device name listed in this FDA 510(k) record. The listed applicant is Harrison-AI Medical Pty, Ltd.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K253818. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Annalise Enterprise?

Annalise Enterprise is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Harrison-AI Medical Pty, Ltd.. The 510(k) number is K253818.

When did Annalise Enterprise receive FDA 510(k) clearance?

Annalise Enterprise received FDA 510(k) clearance on 2026-03-03, under 510(k) number K253818.

Who is the listed applicant for Annalise Enterprise?

The FDA 510(k) record lists Harrison-AI Medical Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Annalise Enterprise?

The FDA product code for Annalise Enterprise is QAS.

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Annalise Enterprise

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：QAS）

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