FDA 510(k)

デジタル体温計（使い捨て体温計カバー付き）

K番号: K172861 · 2017-12-19

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

決定日2017-12-19

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

Digital thermometer(with disposable thermometer cover) 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 2017-12-19 under 510(k) number K172861. 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 Digital thermometer(with disposable thermometer cover)?

Digital thermometer(with disposable thermometer cover) is a medical device that received FDA 510(k) clearance on 2017-12-19. The listed applicant is Hangzhou Hua'An Medical&Health Instruments Co.,Ltd. The 510(k) number is K172861.

When did Digital thermometer(with disposable thermometer cover) receive FDA 510(k) clearance?

Digital thermometer(with disposable thermometer cover) received FDA 510(k) clearance on 2017-12-19, under 510(k) number K172861.

Who is the listed applicant for Digital thermometer(with disposable thermometer cover)?

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 Digital thermometer(with disposable thermometer cover)?

The FDA product code for Digital thermometer(with disposable thermometer cover) 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 K160999赤外線額温計

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