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Braemar, Inc.
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MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER is an FDA 510(k)-cleared medical device (K071011) manufactured by Braemar, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 26, 2007. Regulation: 8.