Clearance Summary
Rooti Rx ECG Event Recorder, Rooti Link APP Software received FDA 510(k) clearance under submission number K163694, sponsored by Rooti Labs , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-11-07.
- Submission: K163694
- Applicant / Sponsor: Rooti Labs , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2017-11-07
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.