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K Number
K001388

Validate with FDA (Live)

Device Name
DATA MASTER PERFUSION MONITORING SYSTEM
Manufacturer
DIDECO
Date Cleared
2000-07-28

(87 days)

Product Code
DRY
Regulation Number
870.4330
Type
Abbreviated
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K092463,K103168,K202154
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.

(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).