Clearance Summary
Philips IntelliVue GuardianSoftware (Rev. E.0X) received FDA 510(k) clearance under submission number K212208, sponsored by Philips Medizin Systeme Boeblingen 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 2021-09-30.
- Submission: K212208
- Applicant / Sponsor: Philips Medizin Systeme Boeblingen GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2450
- Decision date: 2021-09-30
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.