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K Number
K002186

Validate with FDA (Live)

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
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K121108,K183574
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).