Clearance Summary
INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 received FDA 510(k) clearance under submission number K111905, sponsored by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-10-04.
- Submission: K111905
- Applicant / Sponsor: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2450
- Decision date: 2011-10-04
Classification & Regulation
This clearance is catalogued under FDA product code DXJ and 21 CFR 870.2450, within the Cardiovascular review panel as a Class II device.