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Kepler Medtec
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ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 is an FDA 510(k)-cleared medical device (K101660) manufactured by Kepler Medtec. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 10, 2010. Regulation: 8.