FDA 510(k)

耳點系統

K 號：K243891 · 2025-03-26

決定日期2025-03-26

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 System is the device name listed in this FDA 510(k) record. The listed applicant is Earlitec Diagnostics. It received FDA 510(k) clearance on 2025-03-26 under 510(k) number K243891. 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 System?

EarliPoint System is a medical device that received FDA 510(k) clearance on 2025-03-26. The listed applicant is Earlitec Diagnostics. The 510(k) number is K243891.

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

EarliPoint System received FDA 510(k) clearance on 2025-03-26, under 510(k) number K243891.

Who is the listed applicant for EarliPoint System?

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 System?

The FDA product code for EarliPoint System 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。

K253442耳點評估系統

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。

K253442耳點評估系統Earlitec Diagnostics K243558Canvas DxCognoa, Inc.K230337耳點Earlitec Diagnostics, Inc.K213882耳點系統Earlitec Diagnostics, Inc.

官方來源

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