FDA 510(k)

フダカンブルートゥースデジタル体温計（モデル：BT-A41CN-BT）

K番号: K160308 · 2016-07-15

決定日2016-07-15

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

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) is the device name listed in this FDA 510(k) record. The listed applicant is Fudakang Industrial Co., Ltd.. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K160308. 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 Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)?

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Fudakang Industrial Co., Ltd.. The 510(k) number is K160308.

When did Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) receive FDA 510(k) clearance?

Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) received FDA 510(k) clearance on 2016-07-15, under 510(k) number K160308.

Who is the listed applicant for Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)?

The FDA 510(k) record lists Fudakang Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)?

The FDA product code for Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) is FLL.

申請者としてFudakang Industrial Co., Ltd.を記載するその他の記録

K172121デジタル体温計

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