FDA 510(k)

腕輪型電子血圧計（モデルFC-BP200、FC-BP201、FC-BP210、FC-BP211、FC-BP220、FC-BP221）

K番号: K231367 · 2023-09-18

決定日2023-09-18

製品コードDXN

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- **政策：medical-regulatory-v1** --- [ここに原文が記載されています] --- **会社名/製品名**：[ここに会社名または製品名が記載されています] **FDA**：食品医薬品局 **510(k)**：510(k)届出 **PMA**：プレマーケティング評価届出 **NCT**：臨床試験登録番号 **PMID**：PubMed ID **識別子**：[ここに識別子が記載されています] **URL**：[ここにURLが記載されています]

決定大幅同等

医療機器の概要

Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Finicare Co., Ltd.. It received FDA 510(k) clearance on 2023-09-18 under 510(k) number K231367. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)?

Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) is a medical device that received FDA 510(k) clearance on 2023-09-18. The listed applicant is Shenzhen Finicare Co., Ltd.. The 510(k) number is K231367.

When did Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) receive FDA 510(k) clearance?

Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) received FDA 510(k) clearance on 2023-09-18, under 510(k) number K231367.

Who is the listed applicant for Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)?

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

What is the FDA product code for Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)?

The FDA product code for Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) is DXN.

申請者としてShenzhen Finicare Co., Ltd.を記載するその他の記録

K252769上腕電子血圧計（FC-BP107、FC-BP123、FC-BP125、FC-BP126、FC-BP127、FC-BP116）K243136非接触式額頭赤外線体温計（FC-IR2000、FC-IR205、FC-IR202、FC-IR206、FC-IR207、FC-IR209）K242721上腕電子血圧計（FC-BP103、FC-BP106、FC-BP113、FC-BP120、FC-BP121、FC-BP130、FC-BP131）K220113上腕電子血圧計（モデルFC-BP100、FC-BP101、FC-BP102、FC-BP110、FC-BP111、FC-BP112）K181215赤外線体温計

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