FDA 510(k)

HALO AP Dx

K 號：K252762 · 2025-11-25

決定日期2025-11-25

產品代碼QKQ

諮詢委員會PA

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：QKQ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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