Clearance Summary
VITA-STAT MODEL 9000-A received FDA 510(k) clearance under submission number K811147, sponsored by Vita-Stat. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1981-06-30.
- Submission: K811147
- Applicant / Sponsor: Vita-Stat
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1110
- Decision date: 1981-06-30
Classification & Regulation
This clearance is catalogued under FDA product code DSK and 21 CFR 870.1110, within the Cardiovascular review panel as a Class II device.