Clearance Summary
ULTRASOUND SCANNER, TYPE 2400 received FDA 510(k) clearance under submission number K024236, 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 2003-01-17.
- Submission: K024236
- 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: 2003-01-17
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.