
Omron Healthcare, Inc.
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MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S is an FDA 510(k)-cleared medical device (K071645) 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 July 1, 2007. Regulation: 8.