Clearance Summary
ULTRASOUND SCANNER TYPE 2102 received FDA 510(k) clearance under submission number K003986, 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 2001-04-03.
- Submission: K003986
- Applicant / Sponsor: B-K Medical A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2001-04-03
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.