FDA 510(k)

DVT-PRO

K 號：K203353 · 2021-04-22

決定日期2021-04-22

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

DVT-PRO is the device name listed in this FDA 510(k) record. The listed applicant is Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2021-04-22 under 510(k) number K203353. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DVT-PRO?

DVT-PRO is a medical device that received FDA 510(k) clearance on 2021-04-22. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K203353.

When did DVT-PRO receive FDA 510(k) clearance?

DVT-PRO received FDA 510(k) clearance on 2021-04-22, under 510(k) number K203353.

Who is the listed applicant for DVT-PRO?

The FDA 510(k) record lists Daesung Maref Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DVT-PRO?

The FDA product code for DVT-PRO is JOW.

其他以 Daesung Maref Co., Ltd. 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。

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相關器械（代碼：JOW）

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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