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FDA 510(k)

Annalise 企业

K号: K253818 · 2026-03-03

决定日期2026-03-03
产品代码QAS
咨询委员会RA
决定实质等同

器械摘要

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.

常见问题

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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相关器械(代码:QAS)

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