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K Number
K001369
Device Name
RESPIEVENTS, VERSION 4.2
Manufacturer
NON-INVASIVE MONITORING SYSTEMS, INC.
Date Cleared
2000-07-26

(86 days)

Product Code
DQK
Regulation Number
870.1425
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
K011903,K012020
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).