Shenzhen Beierkang Technology Co. Ltd. · 89-08 · CHINA
For Shenzhen Beierkang Technology Co. Ltd. · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is Multifunction Infrared Thermometer; product code is 80 F - - LL Thermometer, Electronic, Clinical; date published is 04/20/2016; address is 322 Jingkaidasha Qinghuyuan Longhua Area , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- Shenzhen Beierkang Technology Co. Ltd. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- 322 Jingkaidasha Qinghuyuan Longhua Area , Shenzhen, Guangdong CHINA verified
- Date published
- 04/20/2016 verified
- Product code
- 80 F - - LL Thermometer, Electronic, Clinical verified
- Product
- Multifunction Infrared Thermometer verified
- FDA notes
- Class II Device. The Agency is unable to determine if the product is a device subject to a previously cleared 510(K) due to the lack of information in the product materials. verified
What the source says
Shenzhen Beierkang Technology Co. Ltd. Date Published : 04/20/2016 322 Jingkaidasha Qinghuyuan Longhua Area , Shenzhen, Guangdong CHINA 80 F - - LL Thermometer, Electronic, Clinical Date Published: 04/20/2016 Desc: Multifunction Infrared Thermometer Notes: Class II Device. The Agency is unable to determine if the product is a device subject to a previously cleared 510(K) due to the lack of information in the product materials.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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