Clearance Summary
INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC received FDA 510(k) clearance under submission number K131913, sponsored by Philips Medizin Systeme Boeblingen 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 2013-11-26.
- Submission: K131913
- Applicant / Sponsor: Philips Medizin Systeme Boeblingen GmbH
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2013-11-26
Classification & Regulation
This clearance is catalogued under FDA product code DRG and 21 CFR 870.2910, within the Cardiovascular review panel as a Class II device.