The following data is part of a premarket notification filed by Vita-course Technologies Co., Ltd. with the FDA for Non-invasive Hemodynamic Blood Pressure Monitor.
| Device ID | K190893 |
| 510k Number | K190893 |
| Device Name: | Non-invasive Hemodynamic Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Vita-Course Technologies Co., Ltd. 3F, Block B, Dajiahao Plaza, No. 262, Yu'an 2nd Road, Bao'an District Shenzhen, CN 518101 |
| Contact | Kezheng Ma |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park, Nanshan District Shenzhen, CN 518067 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-05 |
| Decision Date | 2019-08-07 |