Clearance Summary
PATIENT MONITORS MODELS 78701A/78702A received FDA 510(k) clearance under submission number K771572, 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 1977-08-30.
- Submission: K771572
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2050
- Decision date: 1977-08-30
Classification & Regulation
This clearance is catalogued under FDA product code DRR and 21 CFR 870.2050, within the Cardiovascular review panel as a Class II device.