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K Number
K003145
Device Name
ORIGEN BLADDER HOLDER
Manufacturer
ORIGEN BIOMEDICAL, INC.
Date Cleared
2001-04-20

(192 days)

Product Code
DWC
Regulation Number
870.4250
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.4250 Cardiopulmonary bypass temperature controller.

(a)
Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)
Classification. Class II (performance standards).