FDA 510(k)

耳點評估系統

K 號：K253442 · 2026-03-05

決定日期2026-03-05

產品代碼QPF

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

EarliPoint Assessment is the device name listed in this FDA 510(k) record. The listed applicant is Earlitec Diagnostics. It received FDA 510(k) clearance on 2026-03-05 under 510(k) number K253442. The device is classified under product code QPF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EarliPoint Assessment?

EarliPoint Assessment is a medical device that received FDA 510(k) clearance on 2026-03-05. The listed applicant is Earlitec Diagnostics. The 510(k) number is K253442.

When did EarliPoint Assessment receive FDA 510(k) clearance?

EarliPoint Assessment received FDA 510(k) clearance on 2026-03-05, under 510(k) number K253442.

Who is the listed applicant for EarliPoint Assessment?

The FDA 510(k) record lists Earlitec Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EarliPoint Assessment?

The FDA product code for EarliPoint Assessment is QPF.

其他以 Earlitec Diagnostics 為申請人之記錄

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。

K243891耳點系統

相關器械（代碼：QPF）

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。

K243558Canvas DxCognoa, Inc.K243891耳點系統Earlitec Diagnostics K230337耳點Earlitec Diagnostics, Inc.K213882耳點系統Earlitec Diagnostics, Inc.

官方來源

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