Clearance Summary
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B received FDA 510(k) clearance under submission number K993383, 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 2000-02-03.
- Submission: K993383
- Applicant / Sponsor: Hewlett-Packard GmbH
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2000-02-03
Classification & Regulation
This clearance is catalogued under FDA product code DSI and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.