Clearance Summary
DIAGNOSTIC ULTRASOUND SYSTEM, TYPE 3535, MODIFIED received FDA 510(k) clearance under submission number K926332, 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 1994-06-28.
- Submission: K926332
- Applicant / Sponsor: B&K Medical
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1994-06-28
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.