Shenzen Carewell Electronics Co. · 89-08 · CHINA
For Shenzen Carewell Electronics Co. · 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 Ultrasound Scanner | Ultrasound Scanner | Ultrasound Scanner; product code is 85 H - - EM Imager, Ultrasonic Obstetric-Gynecologic | 90 L - - XE Doppler, Fetal, Ultrasound | 90 M - - AA Monitor, Fetal Doppler Ultrasound; date published is 09/16/2009; address is 5a Huating 3 Guangye Rd , Shenzhen, FN CHINA, verified against its source on 2026-09-16.
- Firm
- Shenzen Carewell Electronics Co. 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
- 5a Huating 3 Guangye Rd , Shenzhen, FN CHINA verified
- Date published
- 09/16/2009 verified
- Product code
- 85 H - - EM Imager, Ultrasonic Obstetric-Gynecologic | 90 L - - XE Doppler, Fetal, Ultrasound | 90 M - - AA Monitor, Fetal Doppler Ultrasound each item verified
- Product
- Ultrasound Scanner | Ultrasound Scanner | Ultrasound Scanner each item verified
- FDA notes
- DWPE Date 11/8/2007 | DWPE Date 11/8/2007 | DWPE Date 11/8/2007 each item verified
What the source says
Shenzen Carewell Electronics Co. Date Published : 09/16/2009 5a Huating 3 Guangye Rd , Shenzhen, FN CHINA 85 H - - EM Imager, Ultrasonic Obstetric-Gynecologic Date Published: 08/25/2023 Desc: Ultrasound Scanner Notes: DWPE Date 11/8/2007 90 L - - XE Doppler, Fetal, Ultrasound Date Published: 08/25/2023 Desc: Ultrasound Scanner Notes: DWPE Date 11/8/2007 90 M - - AA Monitor, Fetal Doppler Ultrasound Date Published: 08/25/2023 Desc: Ultrasound Scanner Notes: DWPE Date 11/8/2007
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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