Clearance Summary
AMBU BLUE SENSOR NEO AND NEO X received FDA 510(k) clearance under submission number K053550, sponsored by Ambu A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-10-25.
- Submission: K053550
- Applicant / Sponsor: Ambu A/S
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 2006-10-25
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.