SHENZHEN SINO-K MEDICAL TECHNOLOGY CO., LTD. · 89-08 · CHINA
For SHENZHEN SINO-K MEDICAL 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 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 2026-09-16.
- 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 73 D - - QA Oximeter Date Published: 05/11/2022 Desc: Disposable SpO2 sensor (oximeter) Neonatal (<3kg)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.