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510(k) Data Aggregation
K Number
K992524Device Name
PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES
Manufacturer
ADVANTAGE MEDICAL ELECTRONICS, INC.
Date Cleared
2000-03-01
(217 days)
Product Code
DSA
Regulation Number
870.2900Why did this record match?
Applicant Name (Manufacturer) :
ADVANTAGE MEDICAL ELECTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These patient cables and leadwires are intended to be used with ECG, EKG, Sp02 and Blood Pressure monitoring devices.
Device Description
Advantage Medical Cables are produced using purchased 5 conductor cable and single conductor leadwire, both shielded and un-shielded, which is cut to various lengths, terminated with the appropriate type terminals and housed in a protective covering made from different types of FDA Grade thermoplastic elastomers, (polypropylene and TPR), using an injection molding process and custom built molds to achieve the desired shape and size. The cito-toxticity test results are in Attachment J1.
The most common cable configuration is of a three or five conductor cable with a metal or plastic connector terminated on one end by crimp or solder method, using various keyway configurations depending on the make and model of the monitor, for connection to the monitoring device, and the three or five conductors terminated into a yoke assembly for the leadwires to attach on the other end. The leadwires may be permanently attached to the yoke or terminated on one end with a .060 diameter pin and over molded with the mating DIN style connector and a snap or pinch type connector on the other end for connection to the patient electrodes. The leadwires may be shielded or unshielded construction. See Attachment E2-1 Patient Cable Drawing CB-71330R, and Illustration E1.
Advantage Medical Cables and leadwires are used in conjunction with various patient monitoring equipment such as ECG, EKG, SpO2 and Blood Pressure equipment for short term diagnostic monitoring. They are not intended to be used in any manner other than as the connection between the monitoring equipment and the electrode pads to monitor the signals between the patient and the transmitter/receiver.
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