Clearance Summary
ISA CO2, ISA AX+, ISA OR+ received FDA 510(k) clearance under submission number K103604, sponsored by Phasein AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2011-04-06.
- Submission: K103604
- Applicant / Sponsor: Phasein AB
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1400
- Decision date: 2011-04-06
Classification & Regulation
This clearance is catalogued under FDA product code CCK and 21 CFR 868.1400, within the Anesthesiology review panel as a Class II device.