Clearance Summary
ZS3 and z.one pro Ultrasound Systems received FDA 510(k) clearance under submission number K192410, sponsored by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-12-19.
- Submission: K192410
- Applicant / Sponsor: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2019-12-19
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.