Clearance Summary
AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) received FDA 510(k) clearance under submission number K973985, sponsored by Datex-Engstrom, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1998-10-30.
- Submission: K973985
- Applicant / Sponsor: Datex-Engstrom, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5160
- Decision date: 1998-10-30
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.