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FDA 510(k)

無液壓計式血壓計組合

K 號:K191209 · 2019-06-18

決定日期2019-06-18
產品代碼DXQ
諮詢委員會履歷
決定相當於

器材摘要

Aneroid Type Blood Pressure Kit is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Mars Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2019-06-18 under 510(k) number K191209. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aneroid Type Blood Pressure Kit?

Aneroid Type Blood Pressure Kit is a medical device that received FDA 510(k) clearance on 2019-06-18. The listed applicant is Dongguan Mars Medical Products Co., Ltd.. The 510(k) number is K191209.

When did Aneroid Type Blood Pressure Kit receive FDA 510(k) clearance?

Aneroid Type Blood Pressure Kit received FDA 510(k) clearance on 2019-06-18, under 510(k) number K191209.

Who is the listed applicant for Aneroid Type Blood Pressure Kit?

The FDA 510(k) record lists Dongguan Mars Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aneroid Type Blood Pressure Kit?

The FDA product code for Aneroid Type Blood Pressure Kit is DXQ.

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相關器械(代碼:DXQ)

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。

官方來源

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