Clearance Summary
ULTRASOUND SCANNER SYSTEM BK2300 received FDA 510(k) clearance under submission number K140428, sponsored by B-K Medical Aps. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-05-30.
- Submission: K140428
- Applicant / Sponsor: B-K Medical Aps
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2014-05-30
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.