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K Number
K961144

Validate with FDA (Live)

Device Name
MS-2000
Manufacturer
TOURITU ENGINEERING CO., INC.
Date Cleared
1997-03-12

(356 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K011625,K061961
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).