Essence 55S Large Monitor System— 510(k) K172969

Substantially Equivalent

Shenyang Torch-Bigtide Digital Technology Co., Ltd.

FDA 510(k) clearance K172969 for Essence 55S Large Monitor System, Substantially Equivalent on 2018-01-26. Applicant: Shenyang Torch-Bigtide Digital Technology Co., Ltd..

Clearance details

Applicant: Shenyang Torch-Bigtide Digital Technology Co., Ltd.
Product code: Code DXJ
Advisory panel: Cardiovascular
Date received: 2017-09-26
Decision date: 2018-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenyang, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.