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FDA 510(k)

上臂式電子血壓計系列,電子血壓計:YE650A、YE650D、YE660B、YE670A 及 YE670D

K 號:K170605 · 2018-03-27

決定日期2018-03-27
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2018-03-27 under 510(k) number K170605. 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 Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D?

Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D is a medical device that received FDA 510(k) clearance on 2018-03-27. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K170605.

When did Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D receive FDA 510(k) clearance?

Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D received FDA 510(k) clearance on 2018-03-27, under 510(k) number K170605.

Who is the listed applicant for Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D?

FDA 510(k) 記錄將江蘇玉宇醫療設備與供應有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D?

The FDA product code for Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D is DXN.

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其他以 Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. 為申請人之記錄

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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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