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510(k) Data Aggregation
K Number
K062760Device Name
ORI F6T DRY ECG MONITORING ELECTRODE
Manufacturer
Date Cleared
2006-12-11
(87 days)
Product Code
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
ORBITAL RESEARCH INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ORI F6T Dry ECG Monitoring Electrodes are intended for use in adults (persons 18 years and older) in all ECG monitoring applications where standard ECG monitoring electrodes are used. The F6T Electrodes can be used in short term and long term (up to 2 days) ECG monitoring.
Device Description
The ORI F6T Dry ECG Monitoring Electrode is a non-sterile, single-use, disposable electrode system consisting of a solid, Ag/AgCl-coated conductive polymer element with a mechanical skin interface surface designed to ensure adequate skin interface without the use of a component electrolytic gel. The conductive polymer clement is held in place using a novel adhesive tape patch.
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