The following data is part of a premarket notification filed by Guangzhou Sonostar Technologies Co., Ltd. with the FDA for Wireless Probe Type Ultrasound Scanner (model:uprobe-c; Uprobe-l; Bprobe).
| Device ID | K172750 |
| 510k Number | K172750 |
| Device Name: | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Guangzhou Sonostar Technologies Co., Ltd. 504#, C Building,#27 Yayingshi Road, Science Town Guangzhou, CN 510665 |
| Contact | Weizhong Cai |
| Correspondent | Helen Nan Wenzhou Cytech Information Service Co., Ltd. Room302, NO.21 Building, Kaiyu Garden, Xishan South Road Wenzhou, CN 325000 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-12 |
| Decision Date | 2018-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970672750043 | K172750 | 000 |
| 06970672750029 | K172750 | 000 |