# SHENZHEN SINO-K MEDICAL TECHNOLOGY CO., LTD. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Building 2 4th Floor , West Side Of Xixiang Veterans Industry City, Gongle Community, Xixiang Street; Xinanzhen Baoan , Shenzhen, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 05/11/2022 _(verified: appears in the quote below)_
- **Product code:** 73 D - - QA Oximeter _(verified: appears in the quote below)_
- **Product:** Disposable SpO2 sensor (oximeter) Neonatal (<3kg) _(verified: appears in the quote below)_

## 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)

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).