510(k) K172750
K172750 is an FDA 510(k) premarket notification submitted by Guangzhou Sonostar Technologies Co., Ltd. for the device "Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)". The FDA issued a decision of Substantially Equivalent on Feb 28, 2018. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Guangzhou Sonostar Technologies Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 28, 2018
- Date Received
- Sep 12, 2017
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type
- 510(k)