Model 3000 Opticath Computer

Q: What is the product code of K853018?

The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.

FDA 510(k) K853018 · Oximetrix, Inc.

Substantially Equivalent

510(k) numberK853018

Submission

Device name: Model 3000 Opticath Computer
Applicant: Oximetrix, Inc.
Mountain View, CA, US
Received: July 17, 1985
Decision date: January 13, 1986
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1435
Specialty: Cardiovascular

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K193179	EV1000 Clinical PlatformDXG · Special	Edwards Lifesciences, LLC	12/17/2019SE
K190955	Hypotension Decision AssistDXG · Traditional	Directed Systems, Ltd.	11/27/2019SE
K181372	ArgosDXG · Traditional	Retia Medical, LLC	12/13/2018SE
K172259	PulsioFlex Monitoring SystemDXG · Traditional	Pulsion Medical Systems SE	01/18/2018SE
K163334	LiDCOunity v2 Hemodynamic MonitorDXG · Traditional	Lidco, Ltd.	06/05/2017SE

More from Lidco, Ltd.

510(k)	Device	Decision
K842622	Hemo Static/Esu Scalpel SystemGEI · Traditional	10/23/1984SE
K833966	Pump Infusion Wearable Infusion PumpJSJ · Traditional	01/25/1984SE
K823007	Opticath Heparin Coated, Flow-DirectDYG · Traditional	11/01/1982SE
K821057	Flow Directed Thermal-Dilution InfusionDYG · Traditional	05/18/1982SE
K821056	Flow Directed Thermal-Dilution Catheter · Traditional	05/18/1982SE
K820674	OpticathDQE · Traditional	03/25/1982SE
K811391	Oximetrix Accu Sat CPBDRY · Traditional	07/20/1981SE
K791868	Oximetrix Shaw Hemostatic Surg. Sys.GEI · Traditional	01/04/1980SE
K781879	Heater, Oximeter SystemDQA · Traditional	01/08/1979SE
K781134	Catheter, Thermal Dilution FiberopticDQE · Traditional	08/17/1978SE

Questions and answers

When was Model 3000 Opticath Computer cleared by the FDA?

Model 3000 Opticath Computer (K853018) received a 510(k) decision of Substantially Equivalent on January 13, 1986, 180 days after the submission was received.

What is the product code of K853018?

The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.