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Omron Healthcare, Inc.
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ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 is an FDA 510(k)-cleared medical device (K001671) manufactured by Omron Healthcare, 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 June 29, 2000. Regulation: 8.