FDA 510(k)

C50 and C80 Multi-parameter Patient Monitor

Número K: K191106 · 2019-12-13

RequerenteShenzhen Comen Medical Instruments Co.,Ltd

Data da decisão2019-12-13

Código do produtoMHX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

C50 and C80 Multi-parameter Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K191106. 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 C50 and C80 Multi-parameter Patient Monitor?

C50 and C80 Multi-parameter Patient Monitor is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. The 510(k) number is K191106.

When did C50 and C80 Multi-parameter Patient Monitor receive FDA 510(k) clearance?

C50 and C80 Multi-parameter Patient Monitor received FDA 510(k) clearance on 2019-12-13, under 510(k) number K191106.

Who is the listed applicant for C50 and C80 Multi-parameter Patient Monitor?

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

What is the FDA product code for C50 and C80 Multi-parameter Patient Monitor?

The FDA product code for C50 and C80 Multi-parameter Patient Monitor is MHX.

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Outros registros que listam Shenzhen Comen Medical Instruments Co.,Ltd como candidato(a)

K250854Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)K250190Sequential Compression System (SCD600)K211619Multi-Parameter Patient Monitor K173454Multi-parameter Patient Monitor, models C30

Dispositivos Relacionados (Código: MHX)

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Fonte oficial

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