FDA 510(k)

赤外線体温計、モデル：HW-1

K番号: K211583 · 2021-09-03

申請者Dongguan Simzo Electronic Technology Co., Ltd.

決定日2021-09-03

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 Thermometer, Model: HW-1 is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Simzo Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K211583. 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 Thermometer, Model: HW-1?

Infrared Thermometer, Model: HW-1 is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Dongguan Simzo Electronic Technology Co., Ltd.. The 510(k) number is K211583.

When did Infrared Thermometer, Model: HW-1 receive FDA 510(k) clearance?

Infrared Thermometer, Model: HW-1 received FDA 510(k) clearance on 2021-09-03, under 510(k) number K211583.

Who is the listed applicant for Infrared Thermometer, Model: HW-1?

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

What is the FDA product code for Infrared Thermometer, Model: HW-1?

The FDA product code for Infrared Thermometer, Model: HW-1 is FLL.

申請者としてDongguan Simzo Electronic Technology Co., Ltd.を記載するその他の記録

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