Clearance Summary
SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655 received FDA 510(k) clearance under submission number K024213, sponsored by Siemens Medical Solutions USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-03-23.
- Submission: K024213
- Applicant / Sponsor: Siemens Medical Solutions USA, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2004-03-23
Classification & Regulation
This clearance is catalogued under FDA product code DSI and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.