FDA 510(k)

Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

Número K: K152902 · 2016-02-18

RequerenteShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Data da decisão2016-02-18

Código do produtoMHX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K152902. 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 Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)?

Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K152902.

When did Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) receive FDA 510(k) clearance?

Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) received FDA 510(k) clearance on 2016-02-18, under 510(k) number K152902.

Who is the listed applicant for Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)?

The FDA product code for Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) is MHX.

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