Clearance Summary
Essence 55S Large Monitor System received FDA 510(k) clearance under submission number K172969, sponsored by Shenyang Torch-Bigtide Digital Technology Co., 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 2018-01-26.
- Submission: K172969
- Applicant / Sponsor: Shenyang Torch-Bigtide Digital Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2450
- Decision date: 2018-01-26
Classification & Regulation
This clearance is catalogued under FDA product code DXJ and 21 CFR 870.2450, within the Cardiovascular review panel as a Class II device.