FDA 510(k)

S-Patch Ex Wearable ECG Patch

K 號：K231289 · 2023-08-30

決定日期2023-08-30

產品代碼DSH

諮詢委員會CV

決定Substantially Equivalent

器材摘要

S-Patch Ex Wearable ECG Patch is the device name listed in this FDA 510(k) record. The listed applicant is Wellysis Corp.. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K231289. 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 S-Patch Ex Wearable ECG Patch?

S-Patch Ex Wearable ECG Patch is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Wellysis Corp.. The 510(k) number is K231289.

When did S-Patch Ex Wearable ECG Patch receive FDA 510(k) clearance?

S-Patch Ex Wearable ECG Patch received FDA 510(k) clearance on 2023-08-30, under 510(k) number K231289.

Who is the listed applicant for S-Patch Ex Wearable ECG Patch?

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

What is the FDA product code for S-Patch Ex Wearable ECG Patch?

The FDA product code for S-Patch Ex Wearable ECG Patch is DSH.

其他以 Wellysis Corp. 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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