FDA 510(k)

赤外線耳と額用体温計、モデルYI-100

K番号: K201843 · 2020-10-23

申請者Wenzhou Yosun Medical Technology Co.,Ltd

決定日2020-10-23

製品コードFLL

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

Infrared ear and forehead thermometer, model YI-100 is the device name listed in this FDA 510(k) record. The listed applicant is Wenzhou Yosun Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K201843. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Infrared ear and forehead thermometer, model YI-100?

Infrared ear and forehead thermometer, model YI-100 is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Wenzhou Yosun Medical Technology Co.,Ltd. The 510(k) number is K201843.

When did Infrared ear and forehead thermometer, model YI-100 receive FDA 510(k) clearance?

Infrared ear and forehead thermometer, model YI-100 received FDA 510(k) clearance on 2020-10-23, under 510(k) number K201843.

Who is the listed applicant for Infrared ear and forehead thermometer, model YI-100?

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

What is the FDA product code for Infrared ear and forehead thermometer, model YI-100?

The FDA product code for Infrared ear and forehead thermometer, model YI-100 is FLL.

申請者としてWenzhou Yosun Medical Technology Co.,Ltdを記載するその他の記録

K230889デジタル体温計 K231478デジタル血圧計（モデル：YB-800）

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。