FDA 510(k)

Multi-Parameter Patient Monitor

N.º K: K211619 · 2022-12-29

SolicitanteShenzhen Comen Medical Instruments Co.,Ltd

Fecha de decisión2022-12-29

Código de productoMHX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

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 2022-12-29 under 510(k) number K211619. 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 Multi-Parameter Patient Monitor?

Multi-Parameter Patient Monitor is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. The 510(k) number is K211619.

When did Multi-Parameter Patient Monitor receive FDA 510(k) clearance?

Multi-Parameter Patient Monitor received FDA 510(k) clearance on 2022-12-29, under 510(k) number K211619.

Who is the listed applicant for 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 Multi-Parameter Patient Monitor?

The FDA product code for 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)K191106C50 and C80 Multi-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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