Essence 55SP Large Monitor System— 510(k) K201162
Substantially EquivalentShenyang Torch-Bigtide Digital Technology Co., Ltd.
FDA 510(k) clearance K201162 for Essence 55SP Large Monitor System, Substantially Equivalent on 2020-08-27. Applicant: Shenyang Torch-Bigtide Digital Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenyang Torch-Bigtide Digital Technology Co., Ltd.
- Product code
- Product code DXJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenyang, CN
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More clearances from Shenyang Torch-Bigtide Digital Technology Co., Ltd.
view allAdverse events under product code DXJ
product code DXJ- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . 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.