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K Number
K252842

Validate with FDA (Live)

Device Name
SafeOp 3: Neural Informatix System
Manufacturer
Alphatec Spine, Inc.
Date Cleared
2026-01-11

(125 days)

Product Code
GWF
Regulation Number
882.1870
Type
Traditional
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).