510(k) K170605
Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D by
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
— Product Code DXN
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2018
- Date Received
- March 1, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type