Clearance Summary
Color Doppler Ultrasound System; Model: mEye1 and mEye2 received FDA 510(k) clearance under submission number K182165, sponsored by Shenzhen Well.D 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 2018-12-20.
- Submission: K182165
- Applicant / Sponsor: Shenzhen Well.D Medical Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2018-12-20
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.