Sorba Model CIC-1000, Comp. Impedance Cardiograph

Q: What is the product code of K895017?

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) K895017 · Sorba Medical Systems, Inc.

Substantially Equivalent

510(k) numberK895017

Submission

Device name: Sorba Model CIC-1000, Comp. Impedance Cardiograph
Applicant: Sorba Medical Systems, Inc.
Milwaukee, WI, US
Received: August 8, 1989
Decision date: March 14, 1990
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

Other 510(k)s with product code DXG

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K251275	VitalStream ART Connect; VitalStream-HemoDXG · Traditional	Caretaker Medical	09/26/2025SE
K232048	Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional	Icu Medical	12/20/2023SE
K212529	Hypotension Decision Assist Model HDA-OR2DXG · Special	Directed Systems, Ltd.	11/23/2021SE
K192169	PulsioFlex Monitoring System with ProAQT SensorDXG · Traditional	Pulsion Medical Systems SE	04/30/2020SE
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
K014299	Sorba Steorra Non-Invasive Impedance CardiographDSB · Special	01/30/2002SE
K950389	Sorba Model CIC-1000 Non-Invasive Hemodynamic MonitorDSB · Traditional	08/15/1995SE
K901926	Sorba Model CIC-1000 W/New ElectrodesDXG · Traditional	06/12/1990SE

Questions and answers

When was Sorba Model CIC-1000, Comp. Impedance Cardiograph cleared by the FDA?

Sorba Model CIC-1000, Comp. Impedance Cardiograph (K895017) received a 510(k) decision of Substantially Equivalent on March 14, 1990, 218 days after the submission was received.

What is the product code of K895017?

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