FDA 510(k)

InBody 血壓監測器，型號 BPBIO480KV

K 號：K221764 · 2022-10-07

決定日期2022-10-07

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

InBody Blood pressure monitor, Model BPBIO480KV is the device name listed in this FDA 510(k) record. The listed applicant is Inbody Co., Ltd.. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K221764. 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 InBody Blood pressure monitor, Model BPBIO480KV?

InBody Blood pressure monitor, Model BPBIO480KV is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Inbody Co., Ltd.. The 510(k) number is K221764.

When did InBody Blood pressure monitor, Model BPBIO480KV receive FDA 510(k) clearance?

InBody Blood pressure monitor, Model BPBIO480KV received FDA 510(k) clearance on 2022-10-07, under 510(k) number K221764.

Who is the listed applicant for InBody Blood pressure monitor, Model BPBIO480KV?

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

What is the FDA product code for InBody Blood pressure monitor, Model BPBIO480KV?

The FDA product code for InBody Blood pressure monitor, Model BPBIO480KV is DXN.

其他以 Inbody 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。

K231174BPBIO750 K200560InBody K200442InBody

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.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。