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K Number
K954501

Validate with FDA (Live)

Device Name
BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
Manufacturer
MEDTRONIC BIO-MEDICUS, INC.
Date Cleared
1996-01-16

(110 days)

Product Code
DTY
Regulation Number
870.4410
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K093650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.4410 Cardiopulmonary bypass in-line blood gas sensor.

(a)
Identification. A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.(b)
Classification. Class II (performance standards).