Shenzhen Imdk Medical Technology Co., Ltd. · 89-08 · CHINA
For Shenzhen Imdk 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 Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1 | Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2 | Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2 | Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1; product code is 73 D - - QA Oximeter | 73 D - - QA Oximeter | 74 O - - CH Oximeter, infrared, sporting, aviation | 74 O - - CH Oximeter, infrared, sporting, aviation; date published is 06/08/2022; address is 904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street, , Guangming District , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- Shenzhen Imdk 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
- 904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street, , Guangming District , Shenzhen, Guangdong CHINA verified
- Date published
- 06/08/2022 verified
- Product code
- 73 D - - QA Oximeter | 73 D - - QA Oximeter | 74 O - - CH Oximeter, infrared, sporting, aviation | 74 O - - CH Oximeter, infrared, sporting, aviation each item verified
- Product
- Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1 | Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2 | Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2 | Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1 each item verified
What the source says
Shenzhen Imdk Medical Technology Co., Ltd. Date Published : 06/08/2022 904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street, , Guangming District , Shenzhen, Guangdong CHINA 73 D - - QA Oximeter Date Published: 06/08/2022 Desc: Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1 73 D - - QA Oximeter Date Published: 06/08/2022 Desc: Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2 74 O - - CH Oximeter, infrared, sporting, aviation Date Published: 06/08/2022 Desc: Oxiline Fingertip Pulse Oximeter Pulse 9 Pro Model C101A2 74 O - - CH Oximeter, infrared, sporting, aviation Date Published: 06/08/2022 Desc: Oxiline Fingertip Pulse Oximeter Pulse 7 Pro Model C101B1
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html