The following data is part of a premarket notification filed by Shenyang Torch-bigtide Digital Technology Co., Ltd. with the FDA for Essence 55sp Large Monitor System.
| Device ID | K201162 |
| 510k Number | K201162 |
| Device Name: | Essence 55SP Large Monitor System |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | Shenyang Torch-Bigtide Digital Technology Co., Ltd. No. 18-6B, Yaoyang Road, Huishan Economic Development Area Shenyang, CN 110164 |
| Contact | Fu Ailing |
| Correspondent | Fu Ailing Shenyang Torch-Bigtide Digital Technology Co., Ltd. No. 18-6B, Yaoyang Road, Huishan Economic Development Area Shenyang, CN 110164 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-30 |
| Decision Date | 2020-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970438060065 | K201162 | 000 |