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K Number
K000565
Device Name
MODIFICATION TO NC-STAT
Manufacturer
NEUROMETRIX, INC.
Date Cleared
2000-06-27

(126 days)

Product Code
JXE
Regulation Number
882.1550
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.1550 Nerve conduction velocity measurement device.

(a)
Identification. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.(b)
Classification. Class II (performance standards).