The following data is part of a premarket notification filed by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd with the FDA for Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: Ye650a, Ye650d, Ye660b, Ye670a And Ye670d.
| Device ID | K170605 |
| 510k Number | K170605 |
| Device Name: | Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A And YE670D |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Jiangsu Yuyue Medical Equipment& Supply Co., Ltd Yunyang Industrial Park Danyang, Jiangsu Danyang, CN 212300 |
| Contact | Rong Zhong |
| Correspondent | Rong Zhong Jiangsu Yuyue Medical Equipment& Supply Co., Ltd Yunyang Industrial Park Danyang, Jiangsu Danyang, CN 212300 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-01 |
| Decision Date | 2018-03-27 |
| Summary: | summary |