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FDA 510(k)

Meritrans ECO 可重用壓力傳感器，Meritrans ECO 球帽

K 號：K221782 · 2023-03-17

申請人Merit Medical Pte. , Ltd.
決定日期2023-03-17
產品代碼DRS
諮詢委員會履歷
決定相當於

器材摘要

Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2023-03-17 under 510(k) number K221782. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes?

Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Merit Medical Pte. , Ltd.. The 510(k) number is K221782.

When did Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes receive FDA 510(k) clearance?

Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes received FDA 510(k) clearance on 2023-03-17, under 510(k) number K221782.

Who is the listed applicant for Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes?

The FDA 510(k) record lists Merit Medical Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes?

The FDA product code for Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes is DRS.

相關臨床試驗

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相關器械（代碼：DRS）

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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