FDA 510(k)

HEM-9210T

K 號：K163235 · 2017-04-20

決定日期2017-04-20

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

HEM-9210T is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2017-04-20 under 510(k) number K163235. 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 HEM-9210T?

HEM-9210T is a medical device that received FDA 510(k) clearance on 2017-04-20. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K163235.

When did HEM-9210T receive FDA 510(k) clearance?

HEM-9210T received FDA 510(k) clearance on 2017-04-20, under 510(k) number K163235.

Who is the listed applicant for HEM-9210T?

The FDA 510(k) record lists Omron Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEM-9210T?

The FDA product code for HEM-9210T is DXN.

其他以 Omron Healthcare, Inc. 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。

K261929上臂血壓監測器（BP7155D）OMRON Healthcare, Inc.K254000快樂健康血壓監測器Happy Health, Inc.K262658自動數位血壓監測器（LD-526）Honsun (Nantong) Co., Ltd.K261394臂式全自動數字血壓計（DBP-6186 Plus、DBP-6286B Plus、DBP-61E3 Plus、DBP-61E2 Plus、DBP-62E3B Plus、DBP-62E2B Plus）JOYTECH Healthcare Co., Ltd.K253425臂式全自动數字血壓監測儀（DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P）Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

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