FDA 510(k)

手臂型全自动數字血壓監測器

K 號：K161577 · 2017-02-08

申請人Sejoy Electronics & Instruments Co., Ltd.

決定日期2017-02-08

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Arm-Type Fully Automatic Digital Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Sejoy Electronics & Instruments Co., Ltd.. It received FDA 510(k) clearance on 2017-02-08 under 510(k) number K161577. 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 Arm-Type Fully Automatic Digital Blood Pressure Monitor?

Arm-Type Fully Automatic Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2017-02-08. The listed applicant is Sejoy Electronics & Instruments Co., Ltd.. The 510(k) number is K161577.

When did Arm-Type Fully Automatic Digital Blood Pressure Monitor receive FDA 510(k) clearance?

Arm-Type Fully Automatic Digital Blood Pressure Monitor received FDA 510(k) clearance on 2017-02-08, under 510(k) number K161577.

Who is the listed applicant for Arm-Type Fully Automatic Digital Blood Pressure Monitor?

The FDA 510(k) record lists Sejoy Electronics & Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arm-Type Fully Automatic Digital Blood Pressure Monitor?

The FDA product code for Arm-Type Fully Automatic Digital Blood Pressure Monitor is DXN.

其他以 Sejoy Electronics & Instruments 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。

K153149數位體溫計，型號 MT-1027、MT-4127、MT-1032、MT-4132、MT-4333、MT-4326、MT-4726、MT-4335、MT-4735、MT-09、MT-30、MT-31、MT-36 K153146紅外耳溫計

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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