FDA.reportPublic FDA data

510(k) K234065

Device
CDI OneView Monitoring System
Applicant
Terumo Cardiovascular Systems Corporation
510(k) number
K234065
Product code
DRY
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-25
Date received
2023-12-22
Regulation
870.4330
Classification name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Rahul Reddy Chinkeri
Address
6200 Jackson Rd. Ann Arbor MI US 48103 48103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DRY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202154B-CaptaLivanova Deutschland, GmbH2021-04-01
K202557Quantum Workstation 12 EliteSpectrum Medical , Ltd.2020-10-02
K182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems Corporation2018-11-02
K181923Quantum Workstation 12.1Spectrum Medical , Ltd.2018-08-17
K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , Ltd.2018-03-28
K163657Quantum WorkstationSpectrum Medical , Ltd.2017-01-18
K133157TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6Medtronic, Inc.2014-10-23
K133658CDI BLOOD PARAMETER MONITORING SYSTEM 500Terumo Cardiovascular Systems Corp.2014-07-25
K123039CDI BLOOD PARAMETER MONITORING SYSTEM 500Terumo Cardiovascular Systems Corp.2012-11-20
K110957M4 MONITORSpectrum Medical, Llp2011-05-31
K103168B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)Sorin Group Deutschland GmbH2011-01-06
K091908M3 MONITORSpectrum Medical , Ltd.2009-07-10
K090147BLOOD MONITORING UNIT, MODEL BMU 40Maquet Cardiopulmonary, AG2009-04-22
K072131M3 MONITORSpectrum Medical , Ltd.2007-08-17
K071725M2 MONITORSpectrum Medical , Ltd.2007-07-11