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K Number
K962128
Device Name
TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)
Manufacturer
HEMO SAPIENS, INC.
Date Cleared
1996-11-21

(171 days)

Product Code
DXG
Regulation Number
870.1435
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
K132892
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.1435 Single-function, preprogrammed diagnostic computer.

(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).