The following data is part of a premarket notification filed by Sysmed (china) Co., Ltd with the FDA for Sysmed S/t.
| Device ID | K192177 |
| 510k Number | K192177 |
| Device Name: | SysMed S/T |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SysMed (China) Co., Ltd 11-2-3 No. 17 Wensu Str., Hunnan New Dis. Shenyang, CN 110171 |
| Contact | Yue Jian |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, CN 200120 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-12 |
| Decision Date | 2020-11-25 |