FDA 510(k)

HALO AP Dx

K番号: K252762 · 2025-11-25

決定日2025-11-25

製品コードQKQ

諮問委員会PA （注：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

HALO AP Dx is the device name listed in this FDA 510(k) record. The listed applicant is Indica Labs, LLC. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K252762. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the HALO AP Dx?

HALO AP Dx is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Indica Labs, LLC. The 510(k) number is K252762.

When did HALO AP Dx receive FDA 510(k) clearance?

HALO AP Dx received FDA 510(k) clearance on 2025-11-25, under 510(k) number K252762.

Who is the listed applicant for HALO AP Dx?

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

What is the FDA product code for HALO AP Dx?

The FDA product code for HALO AP Dx is QKQ.

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医療機器の概要

よくある質問

関連機器（コード：QKQ）

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