FDA 510(k)

C50 and C80 Multi-parameter Patient Monitor

N.º K: K191106 · 2019-12-13

SolicitanteShenzhen Comen Medical Instruments Co.,Ltd

Fecha de decisión2019-12-13

Código de productoMHX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Shenzhen Comen Medical Instruments Co.,Ltd como solicitante

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)

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

Fuente oficial

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