Clearance Summary
DISPOS. PRESSURE KIT 1295K SERIES received FDA 510(k) clearance under submission number K843273, sponsored by Hewlett-Packard Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-06-11.
- Submission: K843273
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2850
- Decision date: 1985-06-11
Classification & Regulation
This clearance is catalogued under FDA product code DRS and 21 CFR 870.2850, within the Cardiovascular review panel as a Class II device.