FDA 510(k)

維克斯 VNT200 非觸碰額頭體溫計

K 號：K193213 · 2020-04-28

申請人Kaz USA, Inc., A Helen of Troy Company

決定日期2020-04-28

產品代碼FLL

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Vicks VNT200 No Touch Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. It received FDA 510(k) clearance on 2020-04-28 under 510(k) number K193213. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vicks VNT200 No Touch Forehead Thermometer?

Vicks VNT200 No Touch Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2020-04-28. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K193213.

When did Vicks VNT200 No Touch Forehead Thermometer receive FDA 510(k) clearance?

Vicks VNT200 No Touch Forehead Thermometer received FDA 510(k) clearance on 2020-04-28, under 510(k) number K193213.

Who is the listed applicant for Vicks VNT200 No Touch Forehead Thermometer?

The FDA 510(k) record lists Kaz USA, Inc., A Helen of Troy Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vicks VNT200 No Touch Forehead Thermometer?

The FDA product code for Vicks VNT200 No Touch Forehead Thermometer is FLL.

其他以 Kaz USA, Inc., A Helen of Troy Company 為申請人之記錄

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相關器械（代碼：FLL）

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