The following data is part of a premarket notification filed by Joytech Healthcare Co., Ltd with the FDA for Non-invasive Blood Pressure Measurement Systems.
| Device ID | K190886 |
| 510k Number | K190886 |
| Device Name: | Non-invasive Blood Pressure Measurement Systems |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Joytech Healthcare Co., Ltd No. 365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, CN 311100 |
| Contact | Ren Yunhua |
| Correspondent | Ren Yunhua Joytech Healthcare Co., Ltd No. 365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, CN 311100 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-04 |
| Decision Date | 2019-07-29 |
| Summary: | summary |