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Maxi-Aids, Inc.
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REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T is an FDA 510(k)-cleared medical device (K041778) manufactured by Maxi-Aids, 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 August 30, 2004. Regulation: 8.