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FDA 510(k)

Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D

K-Number: K170605 · 2018-03-27

Decision Date2018-03-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D is a medical device manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2018-03-27 under approval number K170605. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D?

Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D is a medical device that received FDA 510(k) clearance on 2018-03-27. It is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K170605.

When was Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D approved by the FDA?

Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D received FDA 510(k) clearance on 2018-03-27, under approval number K170605.

What company makes Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D?

Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd..

What is the FDA product code for Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D?

The FDA product code for Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D is DXN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.