Clearance Summary
AMBIO REMOTE HEALTH MONITORING SYSTEM received FDA 510(k) clearance under submission number K130676, sponsored by Arrayent Health, LLC D/B/A Ambio Health. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-07-08.
- Submission: K130676
- Applicant / Sponsor: Arrayent Health, LLC D/B/A Ambio Health
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2013-07-08
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.