Clearance Summary
OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 received FDA 510(k) clearance under submission number K100815, sponsored by Oxypulse. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-06-16.
- Submission: K100815
- Applicant / Sponsor: Oxypulse
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2010-06-16
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.