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FDA 510(k)

布蘭恩Thermoscan PRO 6000 耳溫計

K 號：K152748 · 2016-03-01

申請人Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)
決定日期2016-03-01
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

Braun Thermoscan PRO 6000 Ear Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc). It received FDA 510(k) clearance on 2016-03-01 under 510(k) number K152748. 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 Braun Thermoscan PRO 6000 Ear Thermometer?

Braun Thermoscan PRO 6000 Ear Thermometer is a medical device that received FDA 510(k) clearance on 2016-03-01. The listed applicant is Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc). The 510(k) number is K152748.

When did Braun Thermoscan PRO 6000 Ear Thermometer receive FDA 510(k) clearance?

Braun Thermoscan PRO 6000 Ear Thermometer received FDA 510(k) clearance on 2016-03-01, under 510(k) number K152748.

Who is the listed applicant for Braun Thermoscan PRO 6000 Ear Thermometer?

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

What is the FDA product code for Braun Thermoscan PRO 6000 Ear Thermometer?

The FDA product code for Braun Thermoscan PRO 6000 Ear Thermometer is FLL.

相關臨床試驗

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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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