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Viterion Telehealthcare, LLC
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VITERION 100 TELEHEALTH MONITOR is an FDA 510(k)-cleared medical device (K030419) manufactured by Viterion Telehealthcare, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 5, 2003. Regulation: 8.