FDA 510(k)

布蘭氏ThermoScan® 3 高速精準耳溫計

K 號：K161933 · 2016-08-16

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

決定日期2016-08-16

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

The Braun ThermoScan® 3 High Speed Compact Ear 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 2016-08-16 under 510(k) number K161933. 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 The Braun ThermoScan® 3 High Speed Compact Ear Thermometer?

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is a medical device that received FDA 510(k) clearance on 2016-08-16. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K161933.

When did The Braun ThermoScan® 3 High Speed Compact Ear Thermometer receive FDA 510(k) clearance?

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer received FDA 510(k) clearance on 2016-08-16, under 510(k) number K161933.

Who is the listed applicant for The Braun ThermoScan® 3 High Speed Compact Ear 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 The Braun ThermoScan® 3 High Speed Compact Ear Thermometer?

The FDA product code for The Braun ThermoScan® 3 High Speed Compact Ear 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）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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