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K Number
K002029
Device Name
ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION
Manufacturer
ZOLL MEDICAL CORP.
Date Cleared
2000-09-21

(80 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
K032363
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis 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).