K201162 is an FDA 510(k) clearance for the Essence 55SP Large Monitor System. This device is classified as a Display, Cathode-ray Tube, Medical (Class II - Special Controls, product code DXJ).
Submitted by Shenyang Torch-Bigtide Digital Technology Co., Ltd. (Shenyang, CN). The FDA issued a Cleared decision on August 27, 2020, 119 days after receiving the submission on April 30, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2450.
| 510(k) Number | K201162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2020 |
| Decision Date | August 27, 2020 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXJ - Display, Cathode-ray Tube, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2450 |