Clearance Summary
HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE received FDA 510(k) clearance under submission number K942842, 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 1995-02-16.
- Submission: K942842
- Applicant / Sponsor: Hewlett-Packard GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 1995-02-16
Classification & Regulation
This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.