Clearance Summary
SURGERY DISPLAY SYSTEM received FDA 510(k) clearance under submission number K800488, sponsored by Kent Barker & Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1980-04-16.
- Submission: K800488
- Applicant / Sponsor: Kent Barker & Assoc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2060
- Decision date: 1980-04-16
Classification & Regulation
This clearance is catalogued under FDA product code DRQ and 21 CFR 870.2060, within the Cardiovascular review panel as a Class II device.