Clearance Summary
ULTRASOUND SCANNER 2001 received FDA 510(k) clearance under submission number K936024, sponsored by B & K Medical A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-08-22.
- Submission: K936024
- Applicant / Sponsor: B & K Medical A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1995-08-22
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.