The following data is part of a premarket notification filed by Shenzhen Wisonic Medical Technology Co., Ltd. with the FDA for Clover 50/clover60/clover70 Diagnostic Ultrasound System.
| Device ID | K163712 |
| 510k Number | K163712 |
| Device Name: | Clover 50/Clover60/Clover70 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. 1ST AND 5TH FLOOR, NO.6 BUILDING, PINGSHAN TECH PARK TAOYUAN STREET, NANSHAN Shenzhen, CN 518055 |
| Contact | Jiang Xiaosan |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Service Co.,Ltd. 8-9Th Floor, R&D Building, No.26 Qinglan Street Panyu District Guangzhou, CN 510006 |
| 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 | 2016-12-30 |
| Decision Date | 2018-01-02 |
| Summary: | summary |