Clearance Summary
AMBU ASCOPE 2 received FDA 510(k) clearance under submission number K110962, sponsored by Ambu A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2011-11-18.
- Submission: K110962
- Applicant / Sponsor: Ambu A/S
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5730
- Decision date: 2011-11-18
Classification & Regulation
This clearance is catalogued under FDA product code BTR and 21 CFR 868.5730, within the Anesthesiology review panel as a Class II device.