FDA 510(k)

Multi-parameter Patient Monitor, models C30

Número K: K173454 · 2018-08-16

RequerenteShenzhen Comen Medical Instruments Co.,Ltd

Data da decisão2018-08-16

Código do produtoMHX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Multi-parameter Patient Monitor, models C30 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 2018-08-16 under 510(k) number K173454. 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 Multi-parameter Patient Monitor, models C30?

Multi-parameter Patient Monitor, models C30 is a medical device that received FDA 510(k) clearance on 2018-08-16. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. The 510(k) number is K173454.

When did Multi-parameter Patient Monitor, models C30 receive FDA 510(k) clearance?

Multi-parameter Patient Monitor, models C30 received FDA 510(k) clearance on 2018-08-16, under 510(k) number K173454.

Who is the listed applicant for Multi-parameter Patient Monitor, models C30?

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 Multi-parameter Patient Monitor, models C30?

The FDA product code for Multi-parameter Patient Monitor, models C30 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 K191106C50 and C80 Multi-parameter Patient Monitor

Dispositivos Relacionados (Código: MHX)

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland Oy K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

Fonte oficial

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