Clearance Summary
DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535 received FDA 510(k) clearance under submission number K905198, sponsored by Bruel & Kjaer. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1991-08-28.
- Submission: K905198
- Applicant / Sponsor: Bruel & Kjaer
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 1991-08-28
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.