FDA 510(k)

赤外線額温計

K番号: K160999 · 2016-08-01

申請者Hangzhou Hua'An Medical&Health Instruments Co.,Ltd

決定日2016-08-01

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

Infra-red forehead thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Hua'An Medical&Health Instruments Co.,Ltd. It received FDA 510(k) clearance on 2016-08-01 under 510(k) number K160999. 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 Infra-red forehead thermometer?

Infra-red forehead thermometer is a medical device that received FDA 510(k) clearance on 2016-08-01. The listed applicant is Hangzhou Hua'An Medical&Health Instruments Co.,Ltd. The 510(k) number is K160999.

When did Infra-red forehead thermometer receive FDA 510(k) clearance?

Infra-red forehead thermometer received FDA 510(k) clearance on 2016-08-01, under 510(k) number K160999.

Who is the listed applicant for Infra-red forehead thermometer?

The FDA 510(k) record lists Hangzhou Hua'An Medical&Health Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infra-red forehead thermometer?

The FDA product code for Infra-red forehead thermometer is FLL.

申請者としてHangzhou Hua'An Medical&Health Instruments Co.,Ltdを記載するその他の記録

K172870赤外線耳 thermometer モデル：ET-100A、ET-100B、ET-100D、ET-100E、ET-100G、ET-100I、ET-100J K172861デジタル体温計（使い捨て体温計カバー付き）

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