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FDA 510(k)

Tournicare ARMA自動血壓監測器（ARMA-08）

K 號：K253059 · 2026-06-15

申請人Tournicare Pty, Ltd.
決定日期2026-06-15
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) is the device name listed in this FDA 510(k) record. The listed applicant is Tournicare Pty, Ltd.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K253059. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)?

Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Tournicare Pty, Ltd.. The 510(k) number is K253059.

When did Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) receive FDA 510(k) clearance?

Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) received FDA 510(k) clearance on 2026-06-15, under 510(k) number K253059.

Who is the listed applicant for Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)?

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

What is the FDA product code for Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)?

The FDA product code for Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) is DXN.

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。

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相關器械（代碼：DXN）

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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