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510(k) Data Aggregation
K Number
K090180Device Name
TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE
Manufacturer
Date Cleared
2009-06-17
(145 days)
Product Code
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
VERMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Tender-Trode® Prewired electrode is a disposable, noninvasive electrode that is intended to be used for resting ECG monitoring on neonatal and pediatric patients in a hospital setting. These electrodes can be used for short-term or long-term applications, up to 24 hours. The Tender-Trode of prewired electrodes are single-use, non-sterile, disposable and are to be used on intact (uninjured) skin.
Device Description
A conductive solid gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated ABS eyelet, an adhesive cloth substrate, vinyl label, 24" wire w/.060 dia. female socket and polystyrene release liner.
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