Clearance Summary
INTELLIVUE MX40 PATIENT MONITOR received FDA 510(k) clearance under submission number K103646, sponsored by Phillips Medical Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-01-07.
- Submission: K103646
- Applicant / Sponsor: Phillips Medical Systems
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2011-01-07
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.