Clearance Summary
VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE received FDA 510(k) clearance under submission number K134004, sponsored by Cellco Partnership D/B/A Verizon Wireless. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-02-14.
- Submission: K134004
- Applicant / Sponsor: Cellco Partnership D/B/A Verizon Wireless
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2014-02-14
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.