LogoFDA 510(k) Search
K Number
K001388
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
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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).