Clearance Summary
A5 ANESTHESIA DELIVERY SYSTEM received FDA 510(k) clearance under submission number K123211, sponsored by Datascope Corp., Patient Monitoring Division. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2013-02-14.
- Submission: K123211
- Applicant / Sponsor: Datascope Corp., Patient Monitoring Division
- Clearance pathway: Abbreviated
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5160
- Decision date: 2013-02-14
Classification & Regulation
This clearance is catalogued under FDA product code BSZ and 21 CFR 868.5160, within the Anesthesiology review panel as a Class II device.