Clearance Summary
Philips Hemodynamic Application R1.0 received FDA 510(k) clearance under submission number K181311, sponsored by Philips Medical Systems Nederlands B.V.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-09-07.
- Submission: K181311
- Applicant / Sponsor: Philips Medical Systems Nederlands B.V.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2018-09-07
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.