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510(k) Data Aggregation
K Number
K953649Device Name
DISPOSABLE ECG ELECTRODE
Manufacturer
KENDALL-LTP
Date Cleared
1996-06-21
(322 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
KENDALL-LTP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LMI Medical considers their ElectroBlue® ECG Electrodes to be safe and effective for use with electrocardiograph monitors which are used for recording the electric activity of the myocardium to detect abnormal transmission of small electrical impulses through the conductive tissue surrounding the heart, when used according to the intended procedures as related in the instructions accompanying the product. The function of the LMI Medical ElectroBlue® Electrodes is to detect and transmit these small electrical impulses to the electrocardiograph monitors where they are processed and plotted.
Device Description
The products are all the same in their construction using medical grade foam, polypropylene cloth, clear vinyl, medical grade adhesive, silver coated carbon loaded ABS snaps, and a conductive hydrogel with a polyurethane cover release liner.
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