Clearance Summary
ECG recorder and Arrhythmia Detector received FDA 510(k) clearance under submission number K173461, sponsored by Smart Solutions Technologies SL. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-08-03.
- Submission: K173461
- Applicant / Sponsor: Smart Solutions Technologies SL
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2018-08-03
Classification & Regulation
This clearance is catalogued under FDA product code DSH and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.