LogoFDA 510(k) Search
K Number
K950314
Device Name
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
Manufacturer
DANTEC MEDICAL, INC.
Date Cleared
1996-03-25

(424 days)

Product Code
GXZ
Regulation Number
882.1350
Type
Traditional
Panel
Neurology
Reference & Predicate Devices
N/A
Predicate For
K011702
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 882.1350 Needle electrode.

(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).