
Vivometrics, Inc.
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LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE is an FDA 510(k)-cleared medical device (K043604) manufactured by Vivometrics, 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 28, 2005. Regulation: 8.