FDA 510(k)

Monitor B125, Monitor B105

Número K: K171580 · 2017-11-01

RequerenteGe Medical Systems (China) Co., Ltd.

Data da decisão2017-11-01

Código do produtoMHX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Monitor B125, Monitor B105 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems (China) Co., Ltd.. It received FDA 510(k) clearance on 2017-11-01 under 510(k) number K171580. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Monitor B125, Monitor B105?

Monitor B125, Monitor B105 is a medical device that received FDA 510(k) clearance on 2017-11-01. The listed applicant is Ge Medical Systems (China) Co., Ltd.. The 510(k) number is K171580.

When did Monitor B125, Monitor B105 receive FDA 510(k) clearance?

Monitor B125, Monitor B105 received FDA 510(k) clearance on 2017-11-01, under 510(k) number K171580.

Who is the listed applicant for Monitor B125, Monitor B105?

The FDA 510(k) record lists Ge Medical Systems (China) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monitor B125, Monitor B105?

The FDA product code for Monitor B125, Monitor B105 is MHX.

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