Clearance Summary
MODIFICATION TO KION ANESTHESIA SYSTEM received FDA 510(k) clearance under submission number K001315, sponsored by Siemens Elema AB. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2000-05-26.
- Submission: K001315
- Applicant / Sponsor: Siemens Elema AB
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5160
- Decision date: 2000-05-26
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.