Clearance Summary
MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 received FDA 510(k) clearance under submission number K082045, 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 2008-08-01.
- Submission: K082045
- Applicant / Sponsor: Spacelabs Medical, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2008-08-01
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.