Clearance Summary
PULSE OXIMETER received FDA 510(k) clearance under submission number K855027, sponsored by Physio-Control Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-05-16.
- Submission: K855027
- Applicant / Sponsor: Physio-Control Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 1986-05-16
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.