Clearance Summary
AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849 received FDA 510(k) clearance under submission number K852502, sponsored by Bruel & Kjaer Industri 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 1986-10-23.
- Submission: K852502
- Applicant / Sponsor: Bruel & Kjaer Industri A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1986-10-23
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.