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FDA 510(k)

WHOOP 心電圖功能（1.0）

K 號：K243236 · 2025-04-04

申請人Whoop., Inc.
決定日期2025-04-04
產品代碼QDA
諮詢委員會履歷
決定相當於

器材摘要

WHOOP ECG (electrocardiogram) Feature (1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Whoop., Inc.. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K243236. The device is classified under product code QDA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WHOOP ECG (electrocardiogram) Feature (1.0)?

WHOOP ECG (electrocardiogram) Feature (1.0) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Whoop., Inc.. The 510(k) number is K243236.

When did WHOOP ECG (electrocardiogram) Feature (1.0) receive FDA 510(k) clearance?

WHOOP ECG (electrocardiogram) Feature (1.0) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K243236.

Who is the listed applicant for WHOOP ECG (electrocardiogram) Feature (1.0)?

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

What is the FDA product code for WHOOP ECG (electrocardiogram) Feature (1.0)?

The FDA product code for WHOOP ECG (electrocardiogram) Feature (1.0) is QDA.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：QDA）

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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