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K Number
K003732
Device Name
BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
Manufacturer
BRAUN GMBH
Date Cleared
2001-05-16

(163 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
K142917,K961589,K962401
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).