SHENZHEN SINO-K MEDICAL TECHNOLOGY CO., LTD. · 89-08 · CHINA
For SHENZHEN SINO-K MEDICAL TECHNOLOGY CO., LTD., import alert is 89-08; country is CHINA; 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)"; product is Disposable SpO2 sensor (oximeter) Neonatal (<3kg); product code is 73 D - - QA Oximeter; date published is 05/11/2022; address is Building 2 4th Floor , West Side Of Xixiang Veterans Industry City, Gongle Community, Xixiang Street; Xinanzhen Baoan , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- SHENZHEN SINO-K MEDICAL 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
- Building 2 4th Floor , West Side Of Xixiang Veterans Industry City, Gongle Community, Xixiang Street; Xinanzhen Baoan , Shenzhen, Guangdong CHINA verified
- Date published
- 05/11/2022 verified
- Product code
- 73 D - - QA Oximeter verified
- Product
- Disposable SpO2 sensor (oximeter) Neonatal (<3kg) verified
What the source says
SHENZHEN SINO-K MEDICAL TECHNOLOGY CO., LTD. Date Published : 05/11/2022 Building 2 4th Floor , West Side Of Xixiang Veterans Industry City, Gongle Community, Xixiang Street; Xinanzhen Baoan , Shenzhen, Guangdong CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
73 D - - QA Oximeter Date Published: 05/11/2022 Desc: Disposable SpO2 sensor (oximeter) Neonatal (<3kg)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html