Clearance Summary
NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF received FDA 510(k) clearance under submission number K905101, 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 1990-12-20.
- Submission: K905101
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 1990-12-20
Classification & Regulation
This clearance is catalogued under FDA product code DXQ and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.