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K Number
K002104

Validate with FDA (Live)

Device Name
COMBINED PHYSIOLOGICAL MONITORING SYSTEM
Manufacturer
MARYROSE CUSIMANO, PH.D. & SCOTT ZEFF
Date Cleared
2000-10-10

(90 days)

Product Code
IKN
Regulation Number
890.1375
Type
Traditional
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K022719,K031995
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 890.1375 Diagnostic electromyograph.

(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).