Clearance Summary
HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A received FDA 510(k) clearance under submission number K992674, sponsored by Hewlett-Packard GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-11-08.
- Submission: K992674
- Applicant / Sponsor: Hewlett-Packard GmbH
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1999-11-08
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.