Clearance Summary
VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 received FDA 510(k) clearance under submission number K024359, sponsored by Vista Scientific, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-08-08.
- Submission: K024359
- Applicant / Sponsor: Vista Scientific, LLC
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5300
- Decision date: 2003-08-08
Classification & Regulation
This clearance is catalogued under FDA product code MYU and 21 CFR 882.5300, within the Neurology review panel as a Class II device.