Clearance Summary
WIRELESS MONITORING SYSTEM received FDA 510(k) clearance under submission number K110809, sponsored by Carefusion 303, 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 2011-07-05.
- Submission: K110809
- Applicant / Sponsor: Carefusion 303, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2011-07-05
Classification & Regulation
This clearance is catalogued under FDA product code DRG and 21 CFR 870.2910, within the Cardiovascular review panel as a Class II device.