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Spectralmd, Inc.
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DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K124049) manufactured by Spectralmd, 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 17, 2013. Regulation: 8.