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K Number
K002186
Device Name
VASCULAR ASSIST
Manufacturer
HUNTLEIGH HEALTHCARE, INC.
Date Cleared
2001-05-02

(286 days)

Product Code
DPW,JAF,JOM
Regulation Number
870.2100
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.2100 Cardiovascular blood flowmeter.

(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).