FDA 510(k)

CONTEC08A 電子血圧計、CONTEC08C 電子血圧計、ABPM50 自動血圧計

K番号: K202757 · 2021-04-28

決定日2021-04-28

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

CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical Systems Co.,Ltd. It received FDA 510(k) clearance on 2021-04-28 under 510(k) number K202757. 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 CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor?

CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2021-04-28. The listed applicant is Contec Medical Systems Co.,Ltd. The 510(k) number is K202757.

When did CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor receive FDA 510(k) clearance?

CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor received FDA 510(k) clearance on 2021-04-28, under 510(k) number K202757.

Who is the listed applicant for CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor?

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

What is the FDA product code for CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor?

The FDA product code for CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor is DXN.