Clearance Summary
PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. received FDA 510(k) clearance under submission number K052377, 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 2005-11-17.
- Submission: K052377
- Applicant / Sponsor: Philips Medizin Systeme Boeblingen GmbH
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2005-11-17
Classification & Regulation
This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.