Clearance Summary
Essence 55SP Large Monitor System received FDA 510(k) clearance under submission number K201162, 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 2020-08-27.
- Submission: K201162
- 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: 2020-08-27
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.