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Sentra Medical Devices, LLC
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TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT is an FDA 510(k)-cleared medical device (K062342) manufactured by Sentra Medical Devices, 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 September 24, 2006. Regulation: 8.