Clearance Summary
VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number K122458, sponsored by Cello 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 2013-07-30.
- Submission: K122458
- Applicant / Sponsor: Cello Partnership D/B/A Verizon Wireless
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2013-07-30
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.