Clearance Summary
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 received FDA 510(k) clearance under submission number K120616, sponsored by Spacelabs Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-03-29.
- Submission: K120616
- Applicant / Sponsor: Spacelabs Medical, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2012-03-29
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.