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

K170605 is an FDA 510(k) premarket notification submitted by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. for the device "Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D". The FDA issued a decision of Substantially Equivalent on March 27, 2018. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. has at least 10 other 510(k) clearances on record.

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