FDA 510(k)

Zio® 監護器（DFG0001）

K 號：K243650 · 2025-08-15

決定日期2025-08-15

產品代碼DSH

諮詢委員會履歷

決定相當於

器材摘要

Zio® monitor (DFG0001) is the device name listed in this FDA 510(k) record. The listed applicant is iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K243650. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zio® monitor (DFG0001)?

Zio® monitor (DFG0001) is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is iRhythm Technologies, Inc.. The 510(k) number is K243650.

When did Zio® monitor (DFG0001) receive FDA 510(k) clearance?

Zio® monitor (DFG0001) received FDA 510(k) clearance on 2025-08-15, under 510(k) number K243650.

Who is the listed applicant for Zio® monitor (DFG0001)?

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

What is the FDA product code for Zio® monitor (DFG0001)?

The FDA product code for Zio® monitor (DFG0001) is DSH.

其他以 iRhythm Technologies, Inc. 為申請人之記錄

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相關器械（代碼：DSH）

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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