FDA 510(k)

红外耳/额温计

K号: K190873 · 2019-07-26

决定日期2019-07-26

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

Infrared Ear/Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K190873. 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 Infrared Ear/Forehead Thermometer?

Infrared Ear/Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Joytech Healthcare Co. , Ltd.. The 510(k) number is K190873.

When did Infrared Ear/Forehead Thermometer receive FDA 510(k) clearance?

Infrared Ear/Forehead Thermometer received FDA 510(k) clearance on 2019-07-26, under 510(k) number K190873.

Who is the listed applicant for Infrared Ear/Forehead Thermometer?

FDA 510(k)记录将Joytech Healthcare Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Infrared Ear/Forehead Thermometer?

The FDA product code for Infrared Ear/Forehead Thermometer is FLL.

列明Joytech Healthcare Co. , Ltd.为申报人的其他记录

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。

K261394臂式全自动数字血压计（DBP-6186 Plus，DBP-6286B Plus，DBP-61E3 Plus，DBP-61E2 Plus，DBP-62E3B Plus，DBP-62E2B Plus）K253425臂式全自动数字血压计（DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P）K252501手臂式全自动数字血压计（DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L）K252685手臂式全自动数字血压计（DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P）K243468压缩机雾化器（NB-1100）；压缩机雾化器（NB-1101）；压缩机雾化器（NB-1102）；压缩机雾化器（NB-1103）K250548手臂式全自动数字血压计（DBP-6286B, DBP-6186）

查看所有 24 个设备 →

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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官方来源

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