Clearance Summary
ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 received FDA 510(k) clearance under submission number K081154, sponsored by B-K Medical Aps. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-05-23.
- Submission: K081154
- Applicant / Sponsor: B-K Medical Aps
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2008-05-23
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.