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

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