Clearance Summary
SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE received FDA 510(k) clearance under submission number K090556, sponsored by Spacelabs Healthcare Medical Equipment (Suzhou) CO. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-04-30.
- Submission: K090556
- Applicant / Sponsor: Spacelabs Healthcare Medical Equipment (Suzhou) CO
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2009-04-30
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.