Clearance Summary
ULTRASOUND SCANNER, MODEL TYPE 2101 received FDA 510(k) clearance under submission number K991937, sponsored by B & K Medical A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-07-30.
- Submission: K991937
- Applicant / Sponsor: B & K Medical A/S
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1999-07-30
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.