Clearance Summary
ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 received FDA 510(k) clearance under submission number K043524, sponsored by B-K Medical A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-01-13.
- Submission: K043524
- Applicant / Sponsor: B-K Medical A/S
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2005-01-13
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.