The following data is part of a premarket notification filed by Wuhan Zoncare Bio-medical Electronics Co., Ltd with the FDA for Full Digital Colour Doppler Ultrasonic Diagnostic System.
| Device ID | K183041 |
| 510k Number | K183041 |
| Device Name: | Full Digital Colour Doppler Ultrasonic Diagnostic System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Wuhan Zoncare Bio-medical Electronics Co., Ltd Zoncare Building, #380, High-tech 2ND Road Eastlake High-tech District Wuhan, CN 430206 |
| Contact | Chenglin Tian |
| Correspondent | Long Yang Shenzhen Hlongmed Biotech Co., Ltd. 1002, 10th Floor, Zhongxing Administrative Building Zhongxing Industrial Zone, Chuangye Road, Nanshan Shenzhen, CN 518054 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-01 |
| Decision Date | 2019-07-10 |