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K Number
K010213
Device Name
MODIFICATION TO CAVERMAP SURGICAL AID
Manufacturer
UROMED CORP.
Date Cleared
2001-04-20

(87 days)

Product Code
ETN
Regulation Number
874.1820
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.