FDA 510(k)

トランステック血圧計、ウェルチ・アリンリモートモニタリング血圧装置、ウェルチ・アリンホーム血圧装置

K番号: K161886 · 2016-10-14

申請者Guangdong Transtek Medical Electronics Co., Ltd.

決定日2016-10-14

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

Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K161886. 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 Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device?

Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K161886.

When did Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device receive FDA 510(k) clearance?

Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161886.

Who is the listed applicant for Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device?

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

What is the FDA product code for Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device?

The FDA product code for Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device is DXN.

申請者としてGuangdong Transtek Medical Electronics Co., Ltd.を記載するその他の記録

K243060TeleRPM Gen2 血糖モニタリングシステム K241351血圧計（TMB-2092-G）K240832血圧計（BBZ32-AA01）K240254血圧計（TMB-2296-BT）K240102血圧計（TMB-2287-B）K233130血圧計

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公式ソース

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