Clearance Summary
ULTRASOUND SCANNER 2002 received FDA 510(k) clearance under submission number K943315, sponsored by B&K Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-02-09.
- Submission: K943315
- Applicant / Sponsor: B&K Medical
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1996-02-09
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.