Clearance Summary
MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A received FDA 510(k) clearance under submission number K981576, sponsored by Hewlett-Packard GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-07-17.
- Submission: K981576
- Applicant / Sponsor: Hewlett-Packard GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1998-07-17
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.