Accucom Cardiac Output Monitor

Q: What is the product code of K851426?

The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.

FDA 510(k) K851426 · Lawrence Medical Systems, Inc.

Substantially Equivalent

510(k) numberK851426

Submission

Device name: Accucom Cardiac Output Monitor
Applicant: Lawrence Medical Systems, Inc.
Redmond, WA, US
Received: April 10, 1985
Decision date: July 12, 1985
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: DXK – Echocardiograph
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2330
Specialty: Cardiovascular

Other 510(k)s with product code DXK

510(k)	Device	Applicant	Decision
K181042	Ultra ICE Plus PI 9 MHz Peripheral Imaging CatheterDXK · Special	Boston Scientific Corporation	05/17/2018SE
K160173	Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac…DXK · Special	Boston Scientific Corporation	02/26/2016SE
K031148	In-Vision Imaging SystemDXK · Special	Jomed, Inc.	05/28/2003SE
K934887	9750 Athena Ethernet OptionDXK · Traditional	S & W Medico Teknik A/S	01/14/1994SE
K913209	Accessory to Genesis III (GCFM)DXK · Traditional	Biosound, Inc.	05/15/1992SE
K911384	Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600DXK · Traditional	Endosonics Corp.	06/25/1991SE
K904832	Modified Syst: Sonos 500/1000 Ultrsound Imag SystDXK · Traditional	Hewlett-Packard Co.	04/22/1991SE
K904978	Software Program Used W/Prism ProductsDXK · Traditional	Prism Imaging, Inc.	02/25/1991SE
K904977	Cine/View Plus - Cardiology WorkstationDXK · Traditional	Prism Imaging, Inc.	02/25/1991SE
K904976	Cine'View - Stress Echo & Image ReviewDXK · Traditional	Prism Imaging, Inc.	02/25/1991SE

More from Prism Imaging, Inc.

510(k)	Device	Decision
K874492	Lawrence L4000 Reflectance Pulse OximeterDQA · Traditional	03/22/1988SE
K874885	Lawrence L3000 Cardiac Output MonitorDPW · Traditional	02/05/1988SE
K862548	Temperature Sensing Esophageal TransducerBZT · Traditional	10/22/1986SE

Questions and answers

When was Accucom Cardiac Output Monitor cleared by the FDA?

Accucom Cardiac Output Monitor (K851426) received a 510(k) decision of Substantially Equivalent on July 12, 1985, 93 days after the submission was received.

What is the product code of K851426?

The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.