GE Marquette Clinical Information Center, GE Marquette Cic

Q: What is the product code of K001112?

The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.

FDA 510(k) K001112 · General Electric Medical Systems Information Techn

Substantially Equivalent

510(k) numberK001112

Submission

Device name: GE Marquette Clinical Information Center, GE Marquette Cic
Applicant: General Electric Medical Systems Information Techn
Milwaukee, WI, US
Received: April 6, 2000
Decision date: June 14, 2000
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DXJ – Display, Cathode-Ray Tube, Medical
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2450
Specialty: Cardiovascular

Other 510(k)s with product code DXJ

510(k)	Device	Applicant	Decision
K212003	ESSENZ Patient MonitorDXJ · Special	Livanova Deutschland, GmbH	11/10/2021SE
K212208	Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional	Philips Medizin Systeme Boeblingen GmbH	09/30/2021SE
K201162	Essence 55SP Large Monitor SystemDXJ · Traditional	Shenyang Torch-Bigtide Digital Technology Co.…	08/27/2020SE
K173107	Vios Central Station Monitor Software, Vios Central Server SoftwareDXJ · Traditional	Vios Medical, Inc.	07/26/2018SE
K180534	Philips IntelliVue GuardianSoftwareDXJ · Traditional	Philips Medizin Systeme Boeblingen GmbH	07/16/2018SE
K173381	Nexxis ORDXJ · Special	Barco N.V.	02/22/2018SE
K172969	Essence 55S Large Monitor SystemDXJ · Traditional	Shenyang Torch-Bigtide Digital Technology Co.…	01/26/2018SE
K170460	Sorin ConnectDXJ · Special	Sorin Group Deutschland GmbH	06/08/2017SE
K170537	Nexxis OR, NexxisDXJ · Special	Barco N.V.	04/21/2017SE
K161880	NIVR58-T kitDXJ · Special	Barco N.V.	03/14/2017SE

More from Barco N.V.

510(k)	Device	Decision
K023380	T-Wave Altermans (Twa) Algorithm OptionDQK · Traditional	12/03/2002SE
K021470	Seer Light Compact Digital Holter RecorderMWJ · Traditional	11/14/2002SE
K023100	Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsLLZ · Special	10/11/2002SE
K021454	Unity Network IdMWI · Traditional	10/01/2002SE
K020290	Dash 3000/4000 Patient MonitorMHX · Traditional	08/14/2002SE
K021366	Mac-Lab/Cardiolab Ep/CombolabDQK · Special	07/03/2002SE
K020661	Unity Is Patient ViewerMSX · Traditional	05/24/2002SE
K021325	Modification of Apexpro Telemetry SystemMHX · Special	05/07/2002SE
K020524	Patientnet Monitoring SystemMSX · Special	03/20/2002SE
K012467	Solar 8000M SystemDSI · Traditional	02/11/2002SE

Questions and answers

When was GE Marquette Clinical Information Center, GE Marquette Cic cleared by the FDA?

GE Marquette Clinical Information Center, GE Marquette Cic (K001112) received a 510(k) decision of Substantially Equivalent on June 14, 2000, 69 days after the submission was received.

What is the product code of K001112?

The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.