Clearance Summary
EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE received FDA 510(k) clearance under submission number K081873, sponsored by Shenzhen Emperor Electronic Technology 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 2008-07-16.
- Submission: K081873
- Applicant / Sponsor: Shenzhen Emperor Electronic Technology Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2008-07-16
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.