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FDA 510(k)

Braun BNT400无触点+额温计

K号: K181242 · 2018-07-23

决定日期2018-07-23
产品代码FLL
咨询委员会医疗设备监管文本翻译如下: HO 请注意,由于您没有提供具体的医疗设备监管文本内容,以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

Braun BNT400 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 2018-07-23 under 510(k) number K181242. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Braun BNT400 No Touch + Forehead Thermometer?

Braun BNT400 No Touch + Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2018-07-23. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K181242.

When did Braun BNT400 No Touch + Forehead Thermometer receive FDA 510(k) clearance?

Braun BNT400 No Touch + Forehead Thermometer received FDA 510(k) clearance on 2018-07-23, under 510(k) number K181242.

Who is the listed applicant for Braun BNT400 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 Braun BNT400 No Touch + Forehead Thermometer?

The FDA product code for Braun BNT400 No Touch + Forehead Thermometer is FLL.

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列明Kaz USA, Inc., A Helen of Troy Company为申报人的其他记录

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相关器械(代码:FLL)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

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