Clearance Summary
PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A received FDA 510(k) clearance under submission number K992478, sponsored by Hewlett-Packard, Healthcare Solutions Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-10-15.
- Submission: K992478
- Applicant / Sponsor: Hewlett-Packard, Healthcare Solutions Group
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1999-10-15
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.