FDA 510(k)

RIIマルチ機能赤外線体温計、モデルTH52Z

K番号: K162083 · 2017-01-09

決定日2017-01-09

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

RII Multi-function Infrared Thermometer, Model TH52Z is the device name listed in this FDA 510(k) record. The listed applicant is Radiant Innovation, Inc.. It received FDA 510(k) clearance on 2017-01-09 under 510(k) number K162083. 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 RII Multi-function Infrared Thermometer, Model TH52Z?

RII Multi-function Infrared Thermometer, Model TH52Z is a medical device that received FDA 510(k) clearance on 2017-01-09. The listed applicant is Radiant Innovation, Inc.. The 510(k) number is K162083.

When did RII Multi-function Infrared Thermometer, Model TH52Z receive FDA 510(k) clearance?

RII Multi-function Infrared Thermometer, Model TH52Z received FDA 510(k) clearance on 2017-01-09, under 510(k) number K162083.

Who is the listed applicant for RII Multi-function Infrared Thermometer, Model TH52Z?

The FDA 510(k) record lists Radiant Innovation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RII Multi-function Infrared Thermometer, Model TH52Z?

The FDA product code for RII Multi-function Infrared Thermometer, Model TH52Z is FLL.

申請者としてRadiant Innovation, Inc.を記載するその他の記録

K240648非接触式額頭体温計（TH48FE、TH09F、THD2FE）K163601RII スマート赤外線体温計

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