Clearance Summary
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X received FDA 510(k) clearance under submission number K100129, sponsored by Ambu A/S. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-06-11.
- Submission: K100129
- Applicant / Sponsor: Ambu A/S
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 2010-06-11
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.