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Reflectance Medical, Inc.
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MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER is an FDA 510(k)-cleared medical device (K130079) manufactured by Reflectance Medical, 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 July 18, 2013. Regulation: 8.