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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

Número K: K170605 · 2018-03-27

RequerenteJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Data da decisão2018-03-27
Código do produtoDXN
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K170605.

When did Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D receive FDA 510(k) clearance?

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 510(k) number K170605.

Who is the listed applicant for Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D?

The FDA 510(k) record lists Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Dispositivos Relacionados (Código: DXN)

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Fonte oficial

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