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: Cprobe; Type: Type C, Type L, Type Ct, Type Cl).
| Device ID | K211321 |
| 510k Number | K211321 |
| Device Name: | Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Guangzhou Sonostar Technologies Co., Ltd. 504#, C Building,#27 Yayingshi Road, Science Town Guangzhou, CN 510665 |
| Contact | Weizhong Cai |
| Correspondent | Weizhong Cai Guangzhou Sonostar Technologies Co., Ltd. 504#, C Building,#27 Yayingshi Road, Science Town Guangzhou, CN 510665 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-30 |
| Decision Date | 2022-10-13 |